Suramin in Treating Patients With Recurrent Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006476
• Other study ID #: CRC-PHASE I/II-PH1/073
• Secondary ID: CDR0000068303NCI
• Status: Completed
• Phase: Phase 1
• First received: November 6, 2000
• Last updated: June 25, 2013
• Start date: October 2000
• Est. completion date: October 2007

Study information

• Verified date: March 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• suramin

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United Kingdom	Oxford Radcliffe Hospital	Oxford	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Ord JJ, Streeter E, Jones A, Le Monnier K, Cranston D, Crew J, Joel SP, Rogers MA, Banks RE, Roberts IS, Harris AL. Phase I trial of intravesical Suramin in recurrent superficial transitional cell bladder carcinoma. Br J Cancer. 2005 Jun 20;92(12):2140-7. — View Citation