Suramin in Treating Patients With Recurrent Bladder Cancer

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Research UK
• Treatments: Suramin

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