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BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer Clinical research trials and BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer. BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer  BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
For Condition: stage 4 renal cell cancer,recurrent renal cell cancer
Status: Terminated
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: BAY 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who have recurrent, unresectable, or metastatic kidney cancer.
Details: OBJECTIVES: - Determine the tumor response rate of patients with recurrent, unresectable, or metastatic renal cell carcinoma treated with BAY 56-3722. - Determine the duration of response, time to progression, and survival of patients treated with this drug. - Determine the qualitative and quantitative toxic effects of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive BAY 56-3722 IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months. PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed renal cell carcinoma (RCC) - Recurrent AND unresectable disease OR - Unresectable disease OR - Metastatic disease - At least 1 bidimensionally measurable lesion by CT scan or MRI - No metastatic brain or meningeal tumors unless more than 3 months since prior surgery and/or gamma knife radiosurgery, 2 subsequent negative imaging studies at least 4 weeks apart, clinically stable, and no concurrent corticosteroids or anticonvulsants PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases present) - No chronic hepatitis B or C Renal: - Creatinine no greater than 1.5 mg/dL - Calcium normal Cardiovascular: - No clinically evident congestive heart failure - No serious cardiac arrhythmias - No symptoms of coronary heart disease - No symptoms of ischemia Other: - HIV negative - No active infections requiring systemic antibacterial, antifungal, or antiviral therapy - No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1) - No substance abuse - No medical, psychological, or social conditions that would preclude study - No known or suspected allergy to study drug or any other study agents - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior anticancer vaccine therapy - No prior bone marrow transplantation or stem cell rescue - More than 4 weeks since prior thalidomide and bevacizumab - At least 4 weeks since prior interleukin-2 and interferon - No more than 2 prior regimens - No concurrent bone marrow transplantation or stem cell rescue Chemotherapy: - No prior cytotoxic chemotherapy - No concurrent cytotoxic chemotherapy Endocrine therapy: - See Disease Characteristics - No prior hormonal therapy for RCC - No concurrent hormonal therapy for RCC Radiotherapy: - See Disease Characteristics - More than 4 weeks since prior radiotherapy - No prior radiotherapy to indicator lesion unless progression is documented Surgery: - See Disease Characteristics - More than 3 weeks since prior major surgery Other: - At least 4 weeks since prior investigational anticancer drugs - No other concurrent investigational anticancer drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BarbaraGitlitz, Study Chair, Jonsson Comprehensive Cancer Center
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75390
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615
United States
Oregon Cancer Institute
Portland, Oregon, 97239
United States
Cancer Therapy and Research Center
San Antonio, Texas, 78229-3264
United States
University of Rochester Medical Center
Rochester, New York, 14642-0001
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Oncology-Hematology Group of South Florida
Miami, Florida, 33176
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7353
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Additional Information:
Study ID Numbers: CDR0000069432; BAYER-100364,UCLA-0201019,NCI-G02-2090,UTHSC-0125011152
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040989
Other Recurrent Renal Cell Cancer Studies:
1. Vaccine Therapy in Treating Patients With Kidney Cancer
2. Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment
3. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
4. Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Kidney Cancer or Malignant Melanoma
5. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Metastatic Kidney Cancer
Related Studies:
Other recurrent renal cell cancer Clinical Trials
Other South Carolina Clinical Trials
Other Greenville Clinical Trials
BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
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