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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

For Condition: Bladder Neoplasms,Carcinoma, Transitional Cell
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 18

Location and Contact Information:

National Cancer Institute (NCI)
Bethesda,  Maryland,  20892
United States
 


Additional Information:
Study ID Numbers:
  940098;  94-C-0098
Study Start Date: March 2, 1994
Record last reviewed: January 1, 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001381

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