Suramin in Treating Patients With Recurrent Bladder Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: suramin
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: suramin|nan|
|Procedure: conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage 0 bladder cancer, stage I bladder cancer, recurrent bladder cancer