|
Chemotherapy in Treating Patients With Advanced Kidney Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Chemotherapy in Treating Patients With Advanced Kidney Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Chemotherapy in Treating Patients With Advanced Kidney Cancer Clinical research trials and Chemotherapy in Treating Patients With Advanced Kidney Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Chemotherapy in Treating Patients With Advanced Kidney Cancer. Chemotherapy in Treating Patients With Advanced Kidney Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Chemotherapy in Treating Patients With Advanced Kidney Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Chemotherapy in Treating Patients With Advanced Kidney Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Chemotherapy in Treating Patients With Advanced Kidney Cancer  Chemotherapy in Treating Patients With Advanced Kidney Cancer
Chemotherapy in Treating Patients With Advanced Kidney Cancer
For Condition: stage 4 renal cell cancer,stage 3 renal cell cancer,recurrent renal cell cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Barbara Ann Karmanos Cancer Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who have advanced kidney cancer.
Details: OBJECTIVES: I. Determine the response rate of patients with advanced renal cell carcinoma treated with fenretinide. II. Determine progression-free and overall survival of this patient population treated with this drug. III. Determine the quantitative and qualitative toxic effects of this drug in these patients. PROTOCOL OUTLINE: Patients receive oral fenretinide twice a day for 7 days. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. PROJECTED ACCRUAL: Approximately 18-35 patients will be accrued for this study within 9-21 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed locally advanced unresectable, locally recurrent, or metastatic renal cell carcinoma - Measurable disease; At least 20 mm with conventional techniques OR At least 10 mm with spiral CT scan - No nonmeasurable disease only including: Bone lesions; Leptomeningeal disease; Ascites; Pleural/pericardial effusion; Lymphangitis cutis/pulmonis; Abdominal masses not confirmed and followed by imaging techniques; Cystic lesions; No known brain metastases - History of brain metastases that have been resected and/or irradiated with subsequent normal brain CT scan allowed --Prior/Concurrent Therapy-- - Biologic therapy: Prior biologic therapy allowed - Chemotherapy: No more than 1 prior chemotherapy regimen - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy - Surgery: See Disease Characteristics - Other: Recovered from prior therapy; No prior systemic retinoid therapy; No concurrent antioxidants (e.g., ascorbic acid or vitamin E); No other concurrent therapy for renal cell carcinoma --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 OR Karnofsky 60-100% - Life expectancy: More than 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; AST no greater than 2.5 times upper limit of normal - Renal: Creatinine no greater than 2 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No other prior malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of any site; No history of allergic reactions attributed to compounds of similar chemical or biologic composition to fenretinide; No other concurrent uncontrolled illness (e.g., ongoing or active infection); No concurrent psychiatric illness or social situation that would preclude study; History of HIV allowed if no active infection or history of retinitis; No history of retinal disease, night blindness, or difficulty seeing in the dark
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MahaA. Hussain, Study Chair, Barbara Ann Karmanos Cancer Institute
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Additional Information:
Study ID Numbers: CDR0000068465; NCI-WSU-910,WSU-C-2232
Study Start Date: December 2000
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00011973
Other Recurrent Renal Cell Cancer Studies:
1. Chemotherapy in Treating Patients With Advanced Kidney Cancer
2. ZD 1839 in Treating Patients With Metastatic Kidney Cancer
3. Combination Chemotherapy in Treating Patients With Metastatic Kidney Cancer
4. Tretinoin Plus Interferon alfa in Treating Patients With Metastatic Kidney Cancer
5. Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
Related Studies:
Other recurrent renal cell cancer Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Chemotherapy in Treating Patients With Advanced Kidney Cancer
|
|
|
|
|
|
|
|
