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Suramin in Treating Patients With Recurrent Bladder Cancer

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
suramin
conventional surgery
Sponsored by
Cancer Research UK
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage 0 bladder cancer, stage I bladder cancer, recurrent bladder cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oxford Radcliffe Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 6, 2000
Last Updated
June 25, 2013
Sponsor
Cancer Research UK
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1. Study Identification

Unique Protocol Identification Number
NCT00006476
Brief Title
Suramin in Treating Patients With Recurrent Bladder Cancer
Official Title
A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cancer Research UK

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stage 0 bladder cancer, stage I bladder cancer, recurrent bladder cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
suramin
Intervention Type
Procedure
Intervention Name(s)
conventional surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian L. Harris, MD
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15928663
Citation
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.
Results Reference
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Suramin in Treating Patients With Recurrent Bladder Cancer

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