Completed

Phase 1
All Genders
ID00001381

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

Led by National Cancer Institute (NCI) · Updated on 2008-03-04

18

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 1 location

1

National Cancer Institute (NCI)

Bethesda, Maryland, United States, 20892

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

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