Bladder Cancer
Conditions
Keywords
stage 0 bladder cancer, stage I bladder cancer, recurrent bladder cancer
Brief summary
RATIONALE: Suramin may stop the growth of bladder cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of suramin in treating patients who have recurrent bladder cancer.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose (MTD) of suramin in patients with recurrent superficial bladder cancer. * Confirm that there is no significant systemic absorption of this drug when administered intravesically in these patients. OUTLINE: This is a dose escalation study. At approximately 14-18 days after surgical resection of bladder tumor(s), patients receive intravesicular suramin via urethral catheter installation into the bladder over 2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of suramin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients develop dose-limiting toxicity. Patients are followed at 2-4 weeks. PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study over 1 year.
Interventions
DRUGsuramin
PROCEDUREconventional surgery
Sponsors
Cancer Research UK
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically proven recurrent superficial bladder cancer * Intermediate prognosis as defined by the following: * Recurrent, multiple Ta, T1 carcinoma * Multiple (1-7) tumors * Tumors resected previously must be histological grade G1 or G2 OR * Previously treated superficial bladder cancer requiring followup cystoscopy * Recurrent disease diagnosed at surgery * No tumor invasion into muscle or carcinoma in situ PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm3 * Platelet count at least 150,000/mm3 Hepatic: * No clinically significant hepatic disease Renal: * Creatinine clearance greater than 60 mL/min Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study * No history of adrenal insufficiency * No other malignancy within the past 5 years except adequately treated cone-biopsied carcinoma in situ of the cervix or nonmelanoma skin cancer * No history of difficult catheterization * No confusion or disorientation * No other condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent biologic therapy Chemotherapy: * No concurrent chemotherapy Endocrine therapy: * No concurrent corticosteroids Radiotherapy: * No prior radiotherapy to the bladder * No concurrent radiotherapy Surgery: * See Disease Characteristics * At least 4 weeks since prior major thoracic or abdominal surgery Other: * Recovered from prior therapy and stable for 4 weeks * At least 6 weeks since prior intravesicular therapy * No prior or concurrent investigational drugs * No concurrent anticoagulants
Countries
United Kingdom
Outcome results
None listed