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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00001381
Enrollment
18
Registered
2002-12-10
Start date
1994-03-31
Completion date
2000-12-31
Last updated
2008-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Neoplasms, Carcinoma, Transitional Cell

Keywords

Adult, Intravesical Chemotherapy

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.

Interventions

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026