Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Suramin in Treating Patients With Recurrent Bladder Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	Other	CRC-PHASE I/II-PH1/073 NCI-954, NCT00006476, 954

Objectives

1. Determine the maximum tolerated dose (MTD) of suramin in patients with recurrent superficial bladder cancer.
2. Confirm that there is no significant systemic absorption of this drug when administered intravesically in these patients.

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

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

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

Expected Enrollment

A total of 12-15 patients will be accrued for this study over 1 year.

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.

Ord JJ, Streeter E, Jones A, et al.: Phase I trial of intravesical Suramin in recurrent superficial transitional cell bladder carcinoma. Br J Cancer 92 (12): 2140-7, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals

Adrian Harris, MD, Protocol chair		Ph: 44-1865-226-184

Registry Information
Official Title		A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer
Trial Start Date		2000-10-09
Registered in ClinicalTrials.gov		NCT00006476
Date Submitted to PDQ		2000-09-22
Information Last Verified		2007-03-27

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