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


Phase 1
N/A
N/A
Not Enrolling
Both
Bladder Neoplasms, Carcinoma, Transitional Cell

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

940098

NCT ID:

NCT00001381

Start Date:

March 1994

Completion Date:

December 2000

Related Keywords:

  • Bladder Neoplasms
  • Carcinoma, Transitional Cell
  • Adult
  • Intravesical Chemotherapy
  • Urinary Bladder Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell

Name

Location

National Cancer Institute (NCI) Bethesda, Maryland  20892