Clinical trials are a means of developing new medicines, devices or procedures for the purpose of gaining medical knowledge relevant to the prevention, detection, diagnosis, control, and treatment of medical diseases and conditions. More specifically, clinical trials are scientific studies designed to evaluate one or more groups of subjects, using one or more types of interventions. The predominant intervention studied in clinical research is medicine. Consequently, experimental drugs are the focus of this website.
- Learn about the phases throughout a clinical trial: download pdf.
- Learn about the terminology commonly used in clinical trials: download pdf.
- View a list of individuals involved in UC clinical trials: click here.
Current Clinical Trials
Click on the clinical trial category to jump directly to all clinical trials pertaining to the category:
General Clinical Trials
There are no trials under this category at this time.
Brain Cancer Clinical Trials
Topic: Brain Tumor
Title: RTOG 0424, A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High Risk Low-Grade Gliomas
Place:The Barrett Center and University Pointe
Enrollment Dates: Ongoing
Overview: The purpose of this study is to determine whether a drug called temozolomide combined with radiation will control your tumor longer than radiation alone or radiation combined with other chemotherapy drugs used in previous clinical trials. Temozolomide is FDA approved for some types of brain tumors, however it is not currently approved for low-grade gliomas. This study will find out what effects, good and/or bad, this drug has on you and on your tumor.
Qualifications: Must have a low-grade glioma brain tumor.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
_______________
Topic: Newly Diagnosed Glioblastoma Multiforme (GBM)
Title: A Phase II Clinical Trial Evaluating DCVax®-Brain, Autologous Dendritic Cell Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme
Trial Dates: December 2007 through December 2009 (TEMPORARILY CLOSED)
Place: The Barrett Center and Medical Arts Building
Overview: This study will compare the progression-free survival between patients treated with DCVax-Brain and those given only standard of care therapy.
Qualifications: Patients 18 to 70 years of age with newly diagnosed Glioblastoma Multiforme (GBM).
How to sign up: Call 513-584-7698 or 1-866-724-CURE.
_______________
Topic: Glioblastoma Multiforme
Title: A Phase II Study of CDX-110 with radiation and Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme
Trial Dates: June 2008 through June 2011
Place: The Barrett Center and Medical Arts Building
Overview: This study will evaluate the clinical activity of CDX-110 as defined as an increase in progression-free survival and overall survival as compared to the control group in patients with newly diagnosed Glioblastoma Multiforme.
Qualifications: Subjects must 18 years of age and older with newly diagnosed Glioblastoma Multiforme
How to sign up: Call 513-584-7698 or 1-866-724-CURE.
_______________
Topic: Brain
Title: A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN?, AZD2171] Monotherapy and the Combination of Cediranib With Lomustine to the Efficacy of Lomustine Alone
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building and University Pointe
Overview: The purpose of this study is to see how effective cediranib is in treating a brain tumor called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an approved oral chemotherapy that belongs to the class of drugs called alkylating agents. Cediranib is a new drug that has not yet been approved for this disease. This study will compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo ("inactive substance") to see whether the combination or cediranib alone will be more effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells. You will be randomized (selected by chance, similar to flipping a coin) to receive one of the following three treatment groups. Cediranib alone will be given at a dose of 30mg. You have a two in five, or 40%, chance of receiving this treatment arm. Cediranib will be given at a dose of 20mg in combination with the chemotherapy lomustine. You have a two in five, or 40%, chance of receiving this treatment arm. Chemotherapy lomustine will also be given in combination with a placebo (contains no active medication). You have a one in five, or 20%, chance of receiving this treatment arm.
A total of 300 patients will be accrued for this study, with approximately five patients participating locally.
Qualifications: Eligible patients must be at least 18 years old and have recurrent glioblastoma
How to sign up: Call 513-584-7698 or 1-888-724-5959.
Breast Cancer Clinical Trials
Topic: Breast Cancer
Title: MAP.3 A Phase III Randomized Study of Exemestane Versus Placebo in Women at an Increased Risk of Developing Breast Cancer.
Enrollment Dates: Ongoing
Place: The Barrett Center, Medical Arts Building and University Pointe.
Overview: This five-year study is designed for women who are post-menopausal and at a higher risk of developing breast cancer, due to either a personal or family history of breast cancer. The study compares Exemestane, a drug that is already FDA approved for treating certain types of breast cancer, to a placebo (a sugar pill) taken once a day for five years.
Qualifications: Women must be 35 or older and post-menopausal for at least one year. This can be natural menopause or due to surgery. Calculations are performed to confirm that the potential patient is at a higher risk of developing breast cancer and these calculations must at least meet the minimum number to qualify. Women must not have taken hormone replacement therapy within the past 90 days.
How to sign up: Call (513) 584-7698 or (866) 724-CURE.
_______________
Topic: Breast Cancer
Title: NSABP PROTOCOL BP-59, Bone Marrow Analysis in Early-Stage Breast Cancer
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building and University Pointe
Overview: Diagnostic procedures that detect tumor cells in the bone marrow may help doctors predict disease recurrence and plan more effective treatment. This clinical trial is studying how well diagnostic procedures work in detecting tumor cells in the bone marrow of patients who have undergone surgery for stage I, stage II, or stage IIIA breast cancer. Patients undergo bone marrow aspiration during surgical resection of the primary tumor. Bone marrow cells and tumor samples are analyzed using bright field immunocytochemistry and multicolor fluorescence immunocytochemistry. Patients are followed every 12 months for up to 10 years. A total of 1,634 patients will be accrued for this study within three years.
Qualifications: Eligible patients must be at least 18 years of age and have early-stage breast cancer.
How to sign up: Call (513) 584-7698 or 1 (888) 724-5959.
______________
Topic: Breast Cancer Cancer
Title: NSABP B-40, A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel when Administered before AC with or without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR with each of the Regimens.
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building and University Pointe
Overview: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy and bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known which chemotherapy regimen is more effective with or without bevacizumab in treating breast cancer.
In this research study, eligible patients in Arm I receive docetaxel IV over 60 minutes on day one. Treatment repeats every three weeks for up to four courses. Patients then receive AC comprising doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day one. Treatment repeats every three weeks for up to four courses. Patients then undergo surgery (lumpectomy or mastectomy). Eligible patients in Arm II receive bevacizumab IV over 30-90 minutes on day one and docetaxel as in Arm I. Treatment repeats every three weeks for up to four courses. Patients then receive AC as in Arm I and II additional courses of bevacizumab concurrent with the first two courses of AC. Patients then undergo surgery as in Arm I. At least four to six weeks after surgery, patients receive adjuvant bevacizumab IV over 30 minutes on day one. Treatment repeats every three weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity. Eligible patients in Arm III receive docetaxel as in Arm I and oral capecitabine twice daily on days 1-14. Treatment repeats every three weeks for up to four courses. Patients then receive AC as in Arm I. Patients then undergo surgery as in Arm I. Eligible patients in Arm IV receive bevacizumab as in Arm II and docetaxel and capecitabine as in Arm III. Treatment repeats every three weeks for up to four courses. Patients then receive bevacizumab IV over 30 minutes on day one and AC as in Arm I. Treatment repeats every three weeks for up to four courses (two courses of bevacizumab). Patients then undergo surgery as in Arm I. At least four to six weeks after surgery, patients receive adjuvant bevacizumab as in Arm II. Eligible patients in Arm V receive docetaxel as in Arm I and gemcitabine hydrochloride IV over 30 minutes on days one and eight. Treatment repeats every three weeks for up to four courses. Patients then receive AC as in Arm I. Patients then undergo surgery as in Arm I. Eligible patients in Arm VI receive docetaxel as in Arm I, gemcitabine hydrochloride as in Arm V, and bevacizumab as in Arm II. Patients then receive AC with bevacizumab as in Arm II. Patients then undergo surgery as in Arm I. At least four to six weeks after surgery, patients receive adjuvant bevacizumab as in Arm II.
After completion of study treatment, patients are followed periodically for 10 years.
About five people will take part in the study at the University of Cincinnati and the Department of Veterans Affairs Medical Center. Approximately 1,200 people will take part in this study at multiple institutions across the country.
Qualifications: Qualified participants must be at least 18 years of age, have breast cancer and have not yet had surgery to remove the tumor.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
______________
Topic: Breast Cancer
Title: ECOG PACCT-1 Trial-Program for the Assessment of Clinical Cancer Tests (PACCT-1):Trial Assigning Individualized Options for Treatment: The TAILORx Trial
Enrollment Dates: August 2006 startup
Place: The Barrett Center, Medical Arts Building and University Pointe
Overview: This study is being done because chemotherapy would normally be recommended for the treatment of this disease to lower the risk of breast cancer recurring. The purpose of this study is to determine whether patients who have a tumor with a recurrence score equal to or below 10 may be cured with hormonal therapy alone. Another objective is to create a tissue and blood specimen bank that includes specimens from all women who participate in the study so as to allow researchers to evaluate new diagnostic tests for the future.
Qualifications: To qualify for this trial, women must be age 18 or older and have breast cancer that is estrogen receptor and/or progesterone receptor positive and has not spread to the auxiliary lymph nodes.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
______________
Topic: Breast Cancer
Title: IBCSG 24-02 A phase III trial Evaluating the Role of Ovarian Function Suppression and the role of Exemestane as an Adjuvant Therapy for Premenopausal Women Endocrine Responsive Breast Cancer
Enrollment Dates: Ongoing
Place: The Barrett Center, Medical Arts Building and University Pointe.
Overview: This six-year long study is designed for women who are pre-menopausal and have had surgery for breast cancer. Participants will go into one of three treatment groups: Tamoxifen alone; Suppressing the function of the ovaries plus Tamoxifen; or Suppressing the function of the ovaries plus Exemestane.
Qualifications:
- Women must be 18 or older and pre-menopausal.
- Chemotherapy is not required for this study but, if utilized, must be completed prior to study entry and blood tests will be done to confirm pre-menopausal status.
- Cancer must be confined to the breast and not spread to any other area.
- Contact the study coordinators listed below for other study qualifications.
How to sign up: Call (513) 584-7698 or (866) 724-CURE.
______________
Topic: Breast Cancer
Title: NSABP PROTOCOL B-42: A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Cancer
Enrollment Dates: Ongoing
Place: The Barrett Center, Medical Arts Building and University Pointe
Overview: The main purpose of the study is to learn whether or not continuing hormonal therapy with an aromatase inhibitor (AI) called letrozole for five additional years after already taking five years of hormonal therapy (which included an AI) can further reduce the chance of breast cancer recurrence. Letrozole is investigational (still being researched) for use in patients who have already received an AI as part of their five years of hormonal therapy. Letrozole is considered investigational because it has not yet received approval from the Food and Drug Administration (FDA) or the Canadian Health Products and Food Branch (HPFB) for use after five years of hormonal therapy which included an AI. Eligible patients will be randomized to receive either letrozole 2.5 mg or a placebo that looks like letrozole. Letrozole/placebo should begin within 30 days following randomization and is to be given continuously for five years from the date of the first dose (regardless of missed doses or drug holidays). After completing the letrozole/placebo, study staff will contact patients every year for the rest of their lives to follow their health.
Qualifications: Postmenopausal women with ER and/or PgR-positive invasive breast cancer who have completed five years of hormonal therapy consisting of either five years of an aromatase inhibitor (AI) or up to three years of tamoxifen followed by an AI (for a total of five years).
How to sign up: Call (513) 584-7698 or (866) 724-CURE.
_______________
Topic: Breast Cancer
Title: ALLTO N063D, Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Study: A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building and University Pointe
Overview: This is a randomized, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer.
Patients will be randomized into one of four groups. Some patients in all groups will receive paclitaxel weekly for three months. If you are in Groups One, Three or Four you will receive both paclitaxel and trastuzumab once a week for 12 weeks. Groups One and Four will then receive trastuzumab once every three weeks until you have received one year of treatment. If you are in Group Three you will receive trastuzumab once every week for 12 weeks, then you will have a break for six weeks. After the break you will start taking lapatinib every day until you have received one year of treatment.
After completion of study therapy, you will come to the clinic every three months through Year Two, then every six months until you have been in the study for five years. Then you will come to the clinic once a year until you have been in the study for up to 15 years.
Qualifications: Eligible patients must be at least 18 years of age and have early stage HER2 positive (HER2+) breast cancer that has been surgically removed and you are scheduled to receive paclitaxel.
How to sign up: Call 513-584-7698 or 1-888-724-5959.
______________
Title: SWOG S0226, Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women with Metastatic Breast Cancer
Topic: Breast Cancer
Trial Dates: Ongoing
Place: The Barrett Center, University Hematology Oncology Care and University Pointe.
Overview: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the uptake of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cancer. This randomized phase III trial is studying giving anastrozole together with fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in treating postmenopausal women with metastatic breast cancer. Eligible patients are stratified according to prior adjuvant tamoxifen therapy (yes vs. no). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral anastrozole once daily on days one through 28. Arm II: Patients receive oral anastrozole as in Arm I. Patients also receive fulvestrant intramuscularly on days one, 14, and 28 during course one and then on day 28 of the subsequent courses. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed for up to four years.
A total of 690 patients (345 per treatment arm) will be accrued for this study within three years.
Qualifications: Eligible patients must be postmenopausal women at least 18 years of age and have breast cancer that has metastasized.
How to sign up: Call (513) 584-7698 or 1-888-724-5959.
______________
Topic: Breast Cancer
Title: SWOG S0622, Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building and University Pointe
Overview: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This randomized, phase II trial is studying two different schedules of dasatinib to compare how well they work in treating patients with stage IV breast cancer that has spread to the bone. Eligible patients are stratified according to concurrent trastuzumab (Herceptin®) treatment (yes vs. no). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral dasatinib once daily. Arm II: Patients receive oral dasatinib twice daily. In both treatment arms, treatment continues for at least 24 weeks in the absence of disease progression or unacceptable toxicity. Blood samples are acquired from patients once weekly in weeks one, four, eight, 16, and 24. Samples are analyzed for tumor markers, circulating tumor cells, and bone markers. Patients complete a self-reported brief pain inventory questionnaire at baseline and once in weeks eight, 16, and 24. After completion of study treatment, patients are followed every three to six months for up to two years. A total of 80 patients will be accrued for this study, with about four accrued locally.
Qualifications: Eligible patients must be at least 18 years of age and have breast cancer that has spread to other parts of the body.
How to sign up: Call 513-584-7698 or 1-888-724-5959.
Gastronintestinal Cancer Clinical Trials
Topic: Rectal Cancer
Title: CTSU E5204, Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Pre-operative Chemoradiation
Enrollment Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: This study is being done to compare the effects (good and bad) of a combination of chemotherapy drugs, when given with and without a new drug, bevacizumab, after patients with stage II or stage III rectal cancer have had pre-operative chemoradiation. The chemotherapy drugs given in this study are 5-fluorouracil (5-FU), leucovorin, and oxaliplatin. The researchers want to see if adding bevacizumab to the other cancer-fighting agents is better for treating rectal cancer patients.The researchers also want to see if adding bevacizumab will help prevent the cancer from coming back. The treatment period on the study is approximately six months. The study doctors will follow subjects' medical condition for a period of 10 years after entering the study to look at the long-term effects of the treatment.
Qualifications: Qualified participants must be at least 18 years of age, have stage II or III rectal cancer and have already received chemotherapy, radiation, and surgery for disease treatment.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
_______________
Topic: Study of Oxaliplatin-induced neuropathy in patients with colorectal cancer
Title: Phase II Study of the Efficacy of Amifostine (Ethyol) in Reducing the Incidence and Severity of Oxaliplatin-Induced Neuropathy in Patients with Colorectal Cancer
Enrollment Dates: August 2006 through August 2008
Place: The Barrett Center
Overview: This study will evaluate the use of intravenous Amifostine for reducing the incidence of oxaliplatin-induced neuropathy in patients with colorectal cancer.
Qualifications: Qualified participants must be 18 years of age or older and diagnosed with colorectal cancer
How to sign up: Call (513) 584-7698 or (866) 724-CURE.
_______________
Topic: Colorectal
Title: SWOG S0600, Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) with or without Bevacizumab (NSC-704865) as Second-Line Therapy for Patients with Metastatic Colorectal Cancer who have Progressed on Bevacizumab with Either FOLFOX, OPTIMOX or XELOX
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: This randomized phase III trial is studying irinotecan and cetuximab to compare how well they work with or without bevacizumab in treating patients with metastatic colorectal cancer that progressed during first-line therapy. Eligible patients are stratified according to Zubrod performance status, discontinuation of oxaliplatin during first-line therapy, planned concurrent chemotherapy (FOLFIRI vs. single-agent irinotecan hydrochloride), and time from last dose of bevacizumab (14-42 days vs. ? 43 days). All patients receive either single-agent irinotecan hydrochloride (by IV every 21 days in the absence of disease progression or unacceptable toxicity) or FOLFIRI (by IV every 14 days in the absence of disease progression or unacceptable toxicity). Patients are then randomized to one of three treatment arms. Arm I: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above and cetuximab IV. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above and cetuximab as in Arm I. Patients also receive bevacizumab IV. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity. Arm III: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above and cetuximab as in Arm I. Patients also receive a higher dose of bevacizumab IV (higher than in Arm II). After completion of study treatment, patients are followed every six months for up to three years. A total of 1,260 patients will be accrued for this study, with about 10 accrued locally.
Qualifications: Eligible patients must be at least 18 years of age and have colorectal cancer that has spread and that has not responded to prior treatment that included bevacizumab.
How to sign up: Call 513-584-7698 or 1-888-724-5959.
_______________
Topic: Carcinoid
Title: SWOG S0518, Phase III Prospective Randomized Comparison of Depot Octreotide plus Interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: This randomized phase III trial is studying giving octreotide in combination with interferon alfa-2b to see how well it works compared with giving octreotide in combination with bevacizumab in treating patients with metastatic or locally advanced, high-risk neuroendocrine tumor. Octreotide and interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving octreotide in combination with interferon alfa-2b is more effective than giving octreotide in combination with bevacizumab in treating patients with neuroendocrine tumor. Eligible patients are stratified according to site of disease (small bowel vs. cecum vs. appendix vs. other site), disease progression after initial diagnosis (yes or no), histologic grade (low vs. intermediate [atypical]), and prior octreotide acetate therapy within the past two months (yes vs. no). Patients are randomized to one of two treatment arms. Patients in Arm I receive depot octreotide acetate intramuscularly (IM) and bevacizumab IV over 30-90 minutes on day one. Patients in Arm II receive octreotide acetate IM as in Arm I on day one and interferon alfa-2b subcutaneously (SC) on days one, three, five, eight, 10, 12, 15, 17, and 19. Treatment in both arms repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every two to six months for up to three years.
Qualifications: Eligible patients must be at least 18 years of age and have neuroendocrine carcinoma (carcinoid tumor) that cannot be removed by surgery and has either grown or has at least one feature that suggests it may grow during the period of the study.
How to sign up: Call 513-584-7698 or 1-888-724-5959.
_______________
Topic: Advanced Pancreas Cancer
Title: A Phase II Study of the Combination of Fixed Dose Rate Gemcitabine, Infusional 5-Fluorouracil and Bevacizumab in Patients with Advanced Pancreas Cancer
Trial Dates: November 2006 through June 2008
Place: The Barrett Center
Overview: In this study the combination of the drugs Gemcitabine, 5-fluorouracil and bevacizumab will be tested for safety, tolerability and effectiveness to treat subjects with advanced cancer of the pancreas.
Qualifications: Qualified participants must be 18 years of age or older and diagnosed with advanced pancreas cancer.
How to sign up: Call 513-584-7698 or 1-866-724-CURE.
Genitourinary Cancer Clinical Trials
Topic: Renal (kidney) cancer
Title: CTSU E2805, A Randomized, Double-Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell Carcinoma
Enrollment Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: Sunitinib and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib or sorafenib after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib is more effective than sorafenib or placebo in treating kidney cancer. This randomized phase III trial is studying sunitinib to see how well it works compared to sorafenib or placebo in treating patients with kidney cancer that has been removed by surgery. A total of about 1,332 people will take part in this study at multiple institutions across the country, with approximately five participating locally.
Qualifications: Qualified participants must be at least 18 years of age and have kidney cancer which has just been removed or is about to be removed and is thought to be at high risk of recurrence.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
_______________
Topic: Prostate Cancer
Title: RTOG 0415 -A Phase III Randomized Study of Hypofractionated 3D-CRT/IMRT versus Conventionally Fractionated 3D-CRT/IMRT in Patients with Favorable-Risk Prostate Cancer
Enrollment Dates: Ongoing
Place: The Barrett Center, University Hematology Oncology Care, Veterans Affairs Medical Center and University Pointe
Overview: The purpose of this study is to compare the effects (good and bad) on you and your cancer of the standard dose of radiation therapy (41 treatments over eight weeks) with a higher daily dose (experimental) of radiation (28 treatments over five and a half weeks) to see if the effects of the treatments are similar.
Qualifications:
- Must be 18 years of age or older
- Must have Prostate Cancer and your doctor must have recommended external beam radiation therapy
How to sign up: Call (513) 584-7698 or (888) 724-5959.
_______________
Topic: Prostate Cancer
Title: RTOG 0521 A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT VS AS and 3DCRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized High Risk Prostate Cancer
Place: The Barrett Center, University Pointe and Veterans Affairs Medical Center
Enrollment Dates: April 2006 to 2012 (approx.)
Overview: The main purpose of this study is to try to find out whether adding chemotherapy to the standard treatment for the patient?s stage of prostate cancer is more effective than the standard treatment alone. The kind of treatment that most physicians would consider standard for this stage of prostate cancer combines radiation therapy and hormonal therapy. In this study all patients will receive both of these. In addition, half the patients will also receive chemotherapy drugs for about four to five months. It is hoped that chemotherapy will be found to provide additional benefit, but chemotherapy has significant side effects. The use of chemotherapy is investigational in this stage of prostate cancer; it needs to be tested to determine if it is beneficial and to find out more about the side effects of the two different treatments.
Qualifications:
- Must be at least 18 years of age or older
- Must be localized cancer which has not spread to other tissue
- Must have physician-diagnosed prostate cancer at high risk for recurrence.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
_______________
Topic: Prostate Cancer
Title: RTOG 0534, A Phase III Trial Of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Bed Only Radiotherapy (SPPORT) In Prostate Cancer Patients with A Rising PSA after Radical Prostatectomy
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen deprivation therapy is more effective for prostate cancer. Eligible patients will be put in to three different treatment groups: 1) Patients who receive radiation therapy to the prostate bed only; 2) Patients who receive hormone therapy for four to six months plus radiation therapy to the prostate bed; and 3) Patients who receive hormone therapy for four to six months plus radiation therapy to the prostate bed and to the pelvic lymph nodes. Patient will receive 36?39 radiation treatments over seven to eight weeks. Hormone therapy, if given, will last four to six months. After radiation therapy, participants complete follow-up exams every three months for the first year, then every six months for the next four years. A total of about 1,764 people will take part in this study, with about five people participating locally.
Qualifications: Eligible patients must be at least 18 years old and have had surgery to remove the prostate and be recommended for radiation therapy due to a rise in levels of Prostate Specific Antigen (PSA).
How to sign up: Call 513-584-7698 or 1-888-724-5959.
______________
Topic: Prostate Cancer
Title: CALGB 90202, A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Early versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone
Enrollment Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases. Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases.
This is a randomized, double-blind, placebo-controlled, multicenter study followed by an open-label study. Patients are stratified according to ECOG performance status (0-1 vs. 2), prior skeletal-related event (no vs. yes), and serum alkaline phosphatase (< upper limit of normal [ULN] vs. ULN). Patients are randomized to one of two treatment arms. Patients in Arm I receive zoledronate IV over 15 minutes on day one. Patients in Arm II receive placebo IV over 15 minutes on day one. In both arms, courses repeat every four weeks in the absence of disease progression or a skeletal-related event. All patients receive concurrent androgen deprivation therapy. Patients also receive oral calcium and cholecalciferol (vitamin D) supplements daily.
Patients progressing to androgen-independent prostate cancer proceed to open-label therapy comprising zoledronate IV over 15 minutes on day one. Courses repeat every three weeks in the absence of disease progression or a skeletal-related event. Patients are followed periodically for approximately 10 years after randomization. Projected accrual is a total of 680 patients (340 per treatment arm) will be accrued for this study within four years.
Qualifications: Qualified participants must be at least 18 years of age and have uveal melanoma that has returned after treatment or has spread to other parts of his/her body.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
_______________
Topic: Prostate Cancer
Title: SWOG S0421, Phase III Study of Docetaxel and Atrasentan versus Docetaxel and Placebo For Patients with Advanced Hormone Refractory Prostate Cancer
Enrollment Dates: Ongoing
Place: The Barrett Cancer Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer. This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy.
Eligible patients are randomized to one of two treatment arms. Patients in Arm I receive docetaxel IV over one hour on day one. Patients also receive oral atrasentan and oral prednisone once daily on days one through 21. Treatment repeats every 21 days for up to 12 courses. Patients in Arm II receive docetaxel and prednisone as in Arm I. Patients also receive oral placebo once daily on days one through 21. Treatment repeats every 21 days for up to 12 courses. After completion of study treatment, patients are followed every three months for one year and then every six months for up to three years from study entry. About five people will take part in the study at the University of Cincinnati and the Department of Veterans Affairs Medical Center. Approximately 930 people will take part in this study at multiple institutions across the country.
Qualifications: Qualified participants must be at least 18 years of age and have prostate cancer that is not responding well to treatment.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
Head and Neck Cancer Clinical Trials
There are no trials under this category at this time.
Leukemia Clinical Trials
Topic: Leukemia
Title: SWOG S0605, A Phase II Study of Lenalidomide (Revlimid) (NSC-703813) for Previously Untreated Non-M3 Deletion 5Q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy
Enrollment Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q. During the first part of the study (Induction therapy), patients receive oral lenalidomide once daily on days one through 14, one through 21, or one through 28 (course one). Patients undergo bone marrow biopsy on day 28 or 35 to assess treatment efficacy. Patients with stable or improving disease (i.e., a decrease in blast percentage) without progressive disease proceed to maintenance therapy. During the second part of the study (Maintenance therapy), beginning within 42 days after completion of induction therapy, patients receive oral lenalidomide once daily on days one through 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to five years. A total of about 40 patients will be put on this study, with approximately five patients participating locally.
Qualifications: Qualified participants must be at least 18 years of age and have acute myeloid leukemia (AML) that has not been treated.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
_______________
Topic: Leukemia
Title: S0535, A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients with Previously Untreated High-Risk Acute Promyelocytic Leukemia
Trial Dates: Ongoing
Place: The Medical Arts Building and University Pointe
Overview: This phase II trial is studying how well giving gemtuzumab together with combination chemothearpy works in treating patients with previously untreated promyelocytic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocytic leukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combination chemotherapy may be more effective in treating promyelocytic leukemia. There are three phases of chemotherapy in this study: Induction chemotherapy, Consolidation therapy, and Maintenance therapy. Patients undergo bone marrow aspirates and biopsies periodically during study. Samples are analyzed for cytogenetics by fluorescence in situ hybridization (FISH) and for PML-RAR? by polymerase chain reaction (PCR).
After completion of study treatment, patients are evaluated every three months for one year and then every six months for two years.
Qualifications: Eligible patients must be at least 18 years old and have high-risk acute promyelocytic leukemia (APL) that has never been treated.
How to sign up: Call 513-584-7698 or 1-888-724-5959.
Lung Cancer Clinical Trials
Topic: Lung Cancer
Title: E5597 Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer
Enrollment Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: The study will evaluate how effective taking selenium everyday is in decreasing the number of second primary lung tumors in patients who have been treated for Stage I Non Small Lung Cancer by completely removing their tumor. The study wants to find out the number and severity of side effects people experience when they take selenium every day. The study will compare the overall survival of patients treated with selenium to those patients who are taking placebo. It will also compare the number of occurrences of specific cancers and cancer related deaths in both groups. Treatment consists of taking one pill of either selenium or placebo every day for four years.
Qualifications:
- You must have had a Stage IA non small cell lung cancer that has been completely removed by surgery and are currently free of disease.
- You must have had at least one mediastinal lymph node biopsied at the time of your surgery.
- It must have been at least six months and no more than 36 months since your surgery.
- There must be pathology material from the first diagnosis of your non small cell lung cancer available for review if your cancer recurs.
- You may not have had any chemotherapy or radiation for your lung cancer.
- You must be at least 18 years of age.
- Your blood tests that show how well your liver is working must be within a specified range.
- You must not be taking or plan to take any dietary supplement that contains 50ug or more of selenium.
- You may not have had any other type of cancer except localized, non melanoma skin cancer within the past five years.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
_______________
Topic: Lung Cancer
Title: ACOSOG Z4032 A Randomized Phase III Study of Sublobar Resection versus Sublobar Resection plus Brachytherapy in High Risk Patients with Non-Small Cell Lung Cancer (NSCLC), 3 cm or Smaller.
Enrollment Dates: Ongoing
Place: The Barrett Center, University Hospital, Veterans Affairs Medical Center and University Pointe
Overview: The purpose of this study is to compare the results of sublobar resection (removal of a small portion of a lung) with sublobar resection and brachytherapy (radiation seed implants) on lung cancer.
Qualifications:
- Must be at least 18 year of age
- Must have a suspicious lung nodule for stage I NSCLC
- Must have a mass no more than three cm diameter based on CT scan
- Must not have had previous intra-thoracic radiation therapy
- Women able to have children must have a negative pregnancy test
How to sign up: Call (513) 584-7698 or (888) 724-5959.
_______________
Topic: Lung Cancer
Title: CTSU E1505, A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB-IIIA Non-Small Lung Cancer (NSCLC)
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy in combination with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.
This randomized phase III trial is studying chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery.
Qualified patients are stratified according to type of chemotherapy (cisplatin/vinorelbine ditartrate vs. cisplatin/docetaxel vs. cisplatin/gemcitabine hydrochloride), stage (IB vs. II vs. IIIA [N2] vs. IIIA [T3, N1]), histology (squamous cell vs. other), and gender. Patients are randomized to one of two treatment arms: Arm I (adjuvant chemotherapy without bevacizumab) or Arm II (adjuvant chemotherapy with bevacizumab). Treatment with bevacizumab repeats every 21 days for up to one year. Patients complete smoking status questionnaires at baseline and then every three months during study treatment. After completion of study treatment, patients are followed periodically for 10 years.
A total of 1,500 patients will be accrued for this study, with about 10 accrued locally.
Qualifications: Eligible patients must be at least 18 years of age and have non-small cell lung cancer, which has been removed by a surgeon.
How to sign up: Call 513-584-7698 or 1-888-724-5959.
_______________
Topic
Topic Topic: Lung Cancer
Title: RTOG 0617, Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel in Patient's with Stage IIIA/IIIB Non-Small Cell Lung Cancer
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Trial Dates: Ongoing
Overview: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy in treating patients with non-small cell lung cancer. This randomized phase III trial is studying high-dose radiation therapy given together with chemotherapy to see how well it works compared with standard-dose radiation therapy and chemotherapy in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.
Eligible patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups. Patients in Group One will undergo low-dose radiation therapy fvie days a week for six weeks. They will also receive a one-hour infusion of paclitaxel and an infusion of carboplatin once a week in weeks one through four and six and twice in week five. Patients in Group Two will undergo high-dose radiation therapy five days a week for seven and a half weeks. They will also receive a one-hour infusion of paclitaxel and an infusion of carboplatin once a week in weeks one through four and six and twice in week five. In week 10, patients will receive a three-hour infusion of paclitaxel and an infusion of carboplatin. Treatment may repeat every three weeks for up to two courses. Patients may undergo tumor tissue, blood, and urine collection periodically for laboratory studies. Quality of life may be assessed at the beginning of the study and periodically during the study. After finishing treatment, patients will be evaluated periodically for five years and once a year thereafter.
Qualifications: Eligibility patients must be at least 18 years old, have no distant metastases or Pancoast tumors, have measurable disease, have had no previous chemotherapy for non-small cell lung cancer, and it must be at least three weeks since chest surgery.
How to sign up: Call (513) 584-7698 or 1-866-724-CURE.
________________
Topic: Lung Cancer (Non-Small Cell)
Title: A Pilot (Phase I) Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer
Enrollment Dates: Ongoing
Place: The Barrett Center, University Hematology Oncology Care, Veterans Affairs Medical Center and University Pointe.
Overview: The purpose of this study is to test the safety of cetuximab, docetaxel and concurrent radiation therapy at different dose levels. We also want to find out what effects, good and/or bad, it has on non-small cell lung cancer. This research is being done because many people think that the combination of cetuximab and docetaxel with radiation therapy may be better than the other commonly used combination for non-small cell lung cancer, but these treatments have not been compared. We do not know which of these is better.
Qualifications:
- Must be age 18 years of age or older
- Must have new diagnosis of Stage IIIA or selected Stage IIIB non-small cell lung cancer
How to sign up: Call (513) 584-7698 or (866) 724-CURE.
_______________
Topic: Lung Cancer
Title: S0636, A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (rhuMAb VEGF; NSC-704865) in Never-Smokers with Stage IIIB and IV Primary NSCLC Adenocarcinomas
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving erlotinib in combination with bevacizumab may kill more tumor cells.
This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage IIIB or stage IV primary non-small cell lung cancer who have a minimal smoking history.
Patients receive oral erlotinib hydrochloride daily on days one through 21 and bevacizumab IV over 30-90 minutes on day one. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to three years.
A total of 80 patients will be accrued for this study, with approximately five patients participating locally.
Qualifications: Eligible patients must be at least 18 years of age and have a specific type of non-small cell lung cancer called an adenocarinoma of the lung and the cancer must be present in multiple areas of the lungs and cannot be surgically removed.
How to sign up: Call 513-584-7698 or 1-888-724-5959.
________________
Topic: Lung Cancer
Title: S0635, A Phase II Trial of the Combination of OSI-774 (ERLOTINIB; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) and Adenocarcinoma With BAC Features (ADENOBAC)
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: This phase II trial is studying how well giving erlotinib in combination with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib in combination with bevacizumab may kill more tumor cells.
Patients receive oral erlotinib hydrochloride once daily on days one through 21 and bevacizumab IV over 30-90 minutes on day one. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every three months for one year and then every six months for up to two years.
A total of 80 patients will be accrued for this study, with approximately five patients participating locally.
Qualifications: Eligible patients must be at least 18 years of age and have a specific type of non-small cell lung cancer called bronchioloalveolar carcinoma, or "BAC,? and the cancer must be present in multiple areas of the lungs and cannot be surgically removed.
How to sign up: Call 513-584-7698 or 1-888-724-5959.
________________
Topic: Advanced Non-Small Cell Lung Cancer in Women
Title: Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women with Estradiol > 25pg/mL
Enrollment Dates: October 2007 through January 2008
Place: The Barrett Center and Medical Arts Building
Overview: This study will look at the survival of patients given CT-2103/carboplatin versus patients given paclitaxel/carboplatin. The study will also look at disease control, benefits, response rates, quality of life, safety and tolerability.
Qualifications: Women 18 years of age and older, diagnosed with advanced Non-Small Cell Lung Cancer (NSCLC) who are chemotherapy naïve and have an Estrodiol level of > 30pg/mL. aerodigestive cancers.
How to sign up: Call 513-584-7698 or 1-866-724-CURE.
Lymphoma Clinical Trials
Topic: Lymphoma
Title: SWOG S0520, Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas.
Enrollment Dates: Ongoing (TEMPORARILY CLOSED)
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: The experimental drug PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. Eligible patients receive PXD101 drug PXD101 through a needle in the vein on the first five days of each treatment "cycle." Each dose will last about 30 minutes. Each "cycle" lasts 21 days. This treatment will be repeated every 21 days for as long as the disease is not getting worse. If the disease or symptoms get worse, treatment on this study will be stopped and patients will be offered other treatment by their doctors. After completion of study treatment, patients are followed every three to six months for up to three years. About five people will take part in the study at the University of Cincinnati and the Department of Veterans Affairs Medical Center. Approximately 40 people will take part in this study at multiple institutions across the country.
Qualifications: Qualified participants must be at least 18 years of age and have a kind of cancer called large cell lymphoma. This is a cancer of the lymph nodes, which is potentially curable with current treatments.
How to sign up: Call (513) 584-7698 or (866) 724-CURE.
________________
Topic: Non-Hodgkin's Lymphoma
Title: A Phase III Study of Gemcitabine, Dexamethasone, and Cisplatin Compared with Dexamethasone, Cytarabine, and Cisplatin Plus/Minus Rituximab [(R)-GDP vs (R)-DHAP] as Salvage Chemotherapy for Patients with Relapsed or Refractory Aggressive Histology Non-Hodgkin?s Lymphoma Prior to Autologous Stem Cell Transplant and Followed by Maintenance Rituximab versus Observation.
Enrollment Dates: Ongoing
Place: The Barrett Center, University Hospital and University Pointe
Overview: The purpose of this study is to compare the effectiveness of two different chemotherapy treatments in patients with previously treated non-Hodgkin's lymphoma. Patients in the study will first be treated with either two cycles of gemcitabine, cisplatin, and dexamethasone [(R)-GDP] or with dexamethasone, cytarabine, and cisplatin [(R)-DHAP]. Patients with CD20+ B cell disease will have rituximab combined with their treatment. After chemotherapy has been completed, patients will have a stem cell transplant. Enrolled patients will then be assigned to either long term treatment with rituximab or observation alone.
Qualifications: Patients must be at least 18 years of age and have clinically and/or radiologically confirmed non-Hodgkin's lymphoma that has come back or did not respond (shrink or disappear) with prior treatment with chemotherapy. During treatment, patients must use effective contraception (applies to both women and men) if of childbearing potential. Previous surgery is permissible as long as it has been more than two weeks since any major surgery. Patients may have received prior radiation therapy, and it must have been more than four weeks since last completion of radiation therapy.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
Melanoma Clinical Trials
Topic: Melanoma
Title: SWOG E1697 Phase III Randomized study of Four weeks High dose Interferon Alfa-2b in stage T3-T4 or N1 (microscopic) Melanoma.
Enrollment Dates: Ongoing
Place: The Barrett Center and University Hematology Oncology Care
Overview: The purpose of this study is to compare the effects (good and bad) of treatment with a drug called Interferon Alfa-2b after the surgical removal of melanoma versus surgery followed by observation only. The study will compare to see which is better. Qualified patients will be randomized to Arm I: Observation, or Arm II: Four weeks of High dose Interferon Alfa-2b. Follow-up includes physical exam, blood work and CXR every three months for the first two years, then every six months for three years and then yearly.
Qualifications:
- Only patients with initial presentation of primary melanoma.
- Only patients with cutaneous melanoma.
- Patients must be randomized with 84 days of surgery (wide excision with or without lymphadenectomy).
- No metastatic disease.
- No autoimmune disorders.
- No prior chemotherapy, radiation therapy, immunotherapy or vaccine treatment.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
______________
Topic: Melanoma
Title: S0438, A Randomized Phase II Trial of BAY 43-9006 (Sorafenib; NSC-724772) with Either CCI-779 (Temsirolimus; NSC-683864) or R115777 (Tipifarnib; NSC-702818) in Metastatic Melanoma and Assessment of the Role of PET Imaging for Evaluation as an Early Indicator of Response
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: This randomized phase II trial is studying how well giving sorafenib in combination with either temsirolimus or tipifarnib works in treating patients with stage IV melanoma that cannot be removed by surgery. Sorafenib, temsirolimus, and tipifarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib and tipifarnib may also stop the growth of tumor by blocking blood flow to the tumor. It is not yet known whether sorafenib is more effective when given together with temsirolimus or tipifarnib in treating patients with malignant melanoma.
In Arm I, patients receive oral sorafenib twice daily on days one through 28 and temsirolimus IV over 30 minutes on days one, eight, 15, and 22. In Arm II, patients receive oral sorafenib as in Arm I and oral tipifarnib twice daily on days one through 21.
A total of 110 patients will be accrued for this study, with approximately five patients participating locally.
Qualifications: Eligible patients must be at least 18 years of age and have a type of skin cancer called melanoma that has spread to other organs in your body and cannot be removed by surgery.
How to sign up: Call 513-584-7698 or 1-888-724-5959.
Multiple Myeloma Clinical Trials
There are no trials under this category at this time.
Myelodysplastic Syndrome
There are no trials under this category at this time.
Last Updated 4/10/09
|
