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Fenretinide to Prevent Cancer Recurrence in Treating Patients With Bladder Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Fenretinide to Prevent Cancer Recurrence in Treating Patients With Bladder Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Fenretinide to Prevent Cancer Recurrence in Treating Patients With Bladder Cancer Clinical research trials and Fenretinide to Prevent Cancer Recurrence in Treating Patients With Bladder Cancer healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Fenretinide to Prevent Cancer Recurrence in Treating Patients With Bladder Cancer. Fenretinide to Prevent Cancer Recurrence in Treating Patients With Bladder Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Fenretinide to Prevent Cancer Recurrence in Treating Patients With Bladder Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Fenretinide to Prevent Cancer Recurrence in Treating Patients With Bladder Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Fenretinide to Prevent Cancer Recurrence in Treating Patients With Bladder Cancer  Fenretinide to Prevent Cancer Recurrence in Treating Patients With Bladder Cancer
Fenretinide to Prevent Cancer Recurrence in Treating Patients With Bladder Cancer
For Condition: stage 0 bladder cancer,stage 1 bladder cancer,transitional cell carcinoma of the bladder
Status: No longer recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known if fenretinide is effective in preventing the recurrence of bladder cancer. PURPOSE: Randomizedphase III trial to study the effectiveness of fenretinide in treating patients who are at risk for recurrent bladder cancer following surgery to remove the tumor.
Details: OBJECTIVES: - Determine the efficacy, mechanism of action, and toxicity of fenretinide in patients at risk of recurrent superficial bladder cancer after complete resection of initial tumor. - Determine the treatment effects in modulating the expression of retinoid receptors, chromosomal abnormalities (numerical chromosomal abnormalities and DNA ploidy), apoptosis, and autocrine motility factor receptor (intermediate endpoint markers of recurrent disease) in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lesion type (multifocal vs solitary). Patients are randomized to one of two treatment arms. Patients receive either oral fenretinide or placebo on days 1-25. Courses repeat every 28 days for up to 1 year in the absence of disease progression, unacceptable toxicity, or development of a second primary cancer requiring therapy. Patients are followed every 3 months for 15 months. PROJECTED ACCRUAL: A total of 178 patients (89 per arm) 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 proven solitary or multifocal superficial (stage Ta, grades 1-2) transitional cell carcinoma (TCC) of the bladder meeting 1 of the following criteria: - Newly diagnosed and no more than 4 weeks since resection - Secondary after being tumor free (including carcinoma in situ) for more than 12 months with no intravesical therapy within that 12 months OR - Histologically proven Ta, T1, or Tis TCC of the bladder previously treated with BCG - Must have received 6 weeks of induction BCG followed by no evidence of disease by cystoscopy and cytology and then further treatment with 3 weekly doses of BCG - Visible tumor totally resected within 4 weeks prior to study entry and no further surgery, intravesical therapy, or systemic therapy planned - No prostatic, prostatic urethral, or upper tract TCC involvement by the index tumor at resection - No metastatic disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod (ECOG) 0-2 Life expectancy: - At least 2 years Hematopoietic: - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 11.0 g/dL Hepatic: - SGOT or SGPT less than 1.5 times upper limit of normal (ULN) Renal: - Creatinine less than 2.0 mg/dL Other: - Triglyceride level less than 2.5 times ULN - No other concurrent malignancy except nonmelanomatous skin cancer - No other malignancy within the past 5 years unless currently disease free, at least 6 months since prior therapy, no current or planned active therapy, and expected disease-free survival at least 2 years - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 year after the study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No concurrent systemic biologic therapy Chemotherapy: - See Disease Characteristics - No prior systemic cytotoxic chemotherapy for bladder cancer - At least 1 year since prior cytotoxic chemotherapy for nonbladder cancer - No concurrent systemic chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to the bladder - No concurrent radiotherapy Surgery: - See Disease Characteristics Other: - At least 3 months since prior high-dose vitamin A (greater than 25,000 IU) or beta carotene (at least 30 mg/day) - At least 3 months since prior retinoid therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnitaSabichi, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: CDR0000067387; MDA-ID-95236,NCI-G99-1621
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004154
Other Stage 0 Bladder Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Bladder Cancer
2. BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer
3. Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer
4. Combination Chemotherapy in Treating Patients With Stage II Bladder Cancer
5. Vaccine Therapy in Treating Patients With Transitional Cell Cancer of the Bladder
Related Studies:
Other stage 0 bladder cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Fenretinide to Prevent Cancer Recurrence in Treating Patients With Bladder Cancer
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