Suramin in Treating Patients With Recurrent Bladder Cancer

Cancer Research UK (CRUK)

Status and phase: Completed; Phase 1

Conditions: Bladder Cancer

Treatments: Drug: suramin; Procedure: conventional surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00006476

CRC-PHASE I/II-PH1/073

NCI-954

CDR0000068303 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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