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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Keywords

ClinConnect 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.

Gender

ALL

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.