Bladder Cancer Clinical Trial
Official title:
Intravesical Treatment of Superficial Bladder Cancer Characterized on the Basis of the Tumor Markers p53 and pRb
Verified date | November 2002 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Biological therapies such as BCG use different ways to
stimulate the immune system and stop cancer cells from growing. It is not yet known whether
AD 32 is more effective with or without BCG after surgery for superficial bladder cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of AD 32 with or without BCG
after surgery in treating patients who have newly diagnosed or recurrent superficial bladder
cancer.
Status | Completed |
Enrollment | 0 |
Est. completion date | November 2002 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Newly diagnosed or recurrent (at least 2 occurrences within 12 months) Ta, multifocal Ta (at least 2 visible tumors), or stage T1 bladder cancer - No carcinoma in situ (Tis) only - No T2 or greater tumors - No evidence of upper tract (ureter or renal pelvic) transitional cell carcinoma based on intravenous pyelogram performed within 4 months of the TURB PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - SWOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,500/mm3 - Platelet count greater than 100,000/mm3 Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent biological response modifiers Chemotherapy: - No other concurrent chemotherapy Endocrine therapy: - No concurrent hormonal therapy Radiotherapy: - No concurrent radiotherapy Surgery: - Not specified |
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Anthra Pharmaceuticals |
United States,
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