Bladder Cancer Clinical Trial
Official title:
Randomized Chemoprevention Trial With 4-HPR (Fenretinide) in Superficial Bladder Cancer
Verified date | November 2018 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as fenretinide, 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 fenretinide is more effective than a placebo in preventing the
recurrence of bladder cancer after surgery to remove the tumor.
PURPOSE: This randomized phase III trial is studying fenretinide to see how well it works
compared to a placebo in treating patients who are at risk for recurrent bladder cancer
following surgery to remove the tumor.
Status | Completed |
Enrollment | 111 |
Est. completion date | March 1, 2005 |
Est. primary completion date | March 1, 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 Bacillus Calmette-Guerin (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 (Eastern Cooperative Oncology Group (ECOG)) 0-2 Life expectancy: - At least 2 years Hematopoietic: - white blood count (WBC) greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 11.0 g/dL Hepatic: - serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (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 |
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Veterans Affairs Medical Center - Seattle | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Sabichi AL, Lerner SP, Atkinson EN, Grossman HB, Caraway NP, Dinney CP, Penson DF, Matin S, Kamat A, Pisters LL, Lin DW, Katz RL, Brenner DE, Hemstreet GP 3rd, Wargo M, Bleyer A, Sanders WH, Clifford JL, Parnes HL, Lippman SM. Phase III prevention trial o — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence rate of transitional cell carcinoma (TCC) | Recurrence rates is defined as proportion of participants who recur within one year of surgery. | 1 year |
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