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Suramin in Treating Patients With Recurrent Bladder Cancer



Suramin in Treating Patients With Recurrent Bladder Cancer

For Condition: recurrent bladder cancer,stage 0 bladder cancer,stage 1 bladder cancer
Status: Recruiting
Sponsor(s): Cancer Research UK ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AdrianHarris,  Study Chair,  Oxford Radcliffe Hospital

Oxford Radcliffe Hospital *Recruiting*
Oxford,  England,  0X3 9DU
United Kingdom
Recruiting Adrian  Harris 44-1865-226-184


Additional Information:
Study ID Numbers:  CDR0000068303;  NCI-954,CRC-PHASE I/II-PH1/073
Study Start Date: 
Record last reviewed: December 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006476

Other Recurrent Bladder Cancer Studies:
1. Pemetrexed Disodium in Treating Patients With Locally Advanced or Metastatic Recurrent Cancer of the Urothelium

2. Eflornithine in Treating Patients With Bladder Cancer

3. Gemcitabine in Treating Patients With Recurrent or Refractory Bladder Cancer

4. R115777 in Treating Patients With Advanced Bladder Cancer

5. Arsenic Trioxide in Treating Patients With Recurrent Bladder or Urinary Tract Cancer

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