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Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating patients who have unresectable primary or metastatic kidney cancer that has not been previously treated.


Clinical Trial Description

OBJECTIVES: I. Determine the response rate, duration, and survival in previously untreated patients with hepatocellular carcinoma treated with pyrazoloacridine (PZA). II. Determine the nature, degree, and duration of toxic effects of PZA in these patients.

OUTLINE: Patients receive pyrazoloacridine IV over 3 hours every 3 weeks. The minimum treatment period is 2 courses with tumor restaging at 6 weeks. Patients with complete remission (CR) or partial remission (PR) may continue on treatment until refractory (PR) or for at least 3 additional courses (CR). Patients with stable disease continue on therapy for at least 2 more courses. Patients are followed until death.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 24 months. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00003714
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Withdrawn
Phase Phase 2

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