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A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder

Primary Purpose

Bladder Neoplasms, Carcinoma, Transitional Cell

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
suramin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Neoplasms focused on measuring Adult, Intravesical Chemotherapy

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed superficial transitional cell carcinoma of the bladder pathologically staged as Tis, Ta, or T1. Visible tumors at time of treatment not required. No metastatic disease or muscle invasion. Clinically useful pretreatment bladder function required. No significant prostatic obstructive symptoms associated with impaired or incomplete bladder emptying. No active urinary tract infection. PRIOR/CONCURRENT THERAPY: At least 1 course of prior standard intravesical therapy required. At least 4 weeks since intravesical treatment, with resolution of any local or systemic toxicity. PATIENT CHARACTERISTICS: Age: 18 and over. Performance status: ECOG 0 or 1. Hematopoietic: WBC at least 3,300; Hemoglobin at least 10 g/dL. Hepatic: Bilirubin no greater than 1.5 mg/dL; AST and ALT no greater than 2 times normal. Renal: Creatinine no greater than 1.5 mg/dL. OTHER: Medically able to undergo cystoscopy. No pregnant women.

Sites / Locations

  • National Cancer Institute (NCI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001381
Brief Title
A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder
Official Title
A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2000
Overall Recruitment Status
Completed
Study Start Date
March 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Patients with superficial transitional cell carcinoma of the bladder will be treated with intravesical suramin in a phase I dose escalating study. The toxicity of suramin administered in this fashion will be evaluated.
Detailed Description
Patients with superficial transitional cell carcinoma of the bladder will be treated with intravesical suramin in a phase I dose escalating study. The toxicity of suramin administered in this fashion will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Neoplasms, Carcinoma, Transitional Cell
Keywords
Adult, Intravesical Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
18 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
suramin

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed superficial transitional cell carcinoma of the bladder pathologically staged as Tis, Ta, or T1. Visible tumors at time of treatment not required. No metastatic disease or muscle invasion. Clinically useful pretreatment bladder function required. No significant prostatic obstructive symptoms associated with impaired or incomplete bladder emptying. No active urinary tract infection. PRIOR/CONCURRENT THERAPY: At least 1 course of prior standard intravesical therapy required. At least 4 weeks since intravesical treatment, with resolution of any local or systemic toxicity. PATIENT CHARACTERISTICS: Age: 18 and over. Performance status: ECOG 0 or 1. Hematopoietic: WBC at least 3,300; Hemoglobin at least 10 g/dL. Hepatic: Bilirubin no greater than 1.5 mg/dL; AST and ALT no greater than 2 times normal. Renal: Creatinine no greater than 1.5 mg/dL. OTHER: Medically able to undergo cystoscopy. No pregnant women.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1512858
Citation
Gansler T, Vaghmar N, Olson JJ, Graham SD. Suramin inhibits growth factor binding and proliferation by urothelial carcinoma cell cultures. J Urol. 1992 Sep;148(3):910-4. doi: 10.1016/s0022-5347(17)36776-9.
Results Reference
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PubMed Identifier
8738403
Citation
Walther MM, Figg WD, Linehan WM. Intravesical suramin: a novel agent for the treatment of superficial transitional-cell carcinoma of the bladder. World J Urol. 1996;14 Suppl 1:S8-11. doi: 10.1007/BF00182057.
Results Reference
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PubMed Identifier
7933214
Citation
Walther MM, Trahan EE, Cooper M, Venzon D, Linehan WM. Suramin inhibits proliferation and DNA synthesis in transitional carcinoma cell lines. J Urol. 1994 Nov;152(5 Pt 1):1599-602. doi: 10.1016/s0022-5347(17)32486-2.
Results Reference
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A Phase I Trial Using Suramin to Treat Superficial Transitional Cell Carcinoma of the Bladder

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