Suramin in Treating Patients With Recurrent Bladder Cancer

NCT ID: NCT00006476

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-31
• Study Completion Date: 2007-10-31

Brief 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.

Detailed 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.

Conditions

Bladder Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

suramin

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Research UK

OTHER

Sponsor Role: lead

Principal Investigators

Adrian L. Harris, MD

Role: STUDY_CHAIR

Oxford University Hospitals NHS Trust

Locations

Oxford Radcliffe Hospital

Oxford, England, United Kingdom

Countries

United Kingdom

References

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. doi: 10.1038/sj.bjc.6602650.

Reference Type: RESULT

PMID: 15928663 (View on PubMed)

Other Identifiers

CDR0000068303

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-954

Identifier Type: -

Identifier Source: secondary_id

CRC-PHASE I/II-PH1/073

Identifier Type: -

Identifier Source: org_study_id