NCT00005976

Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma

Phase I/II Trial of Pyrazoloacridine and Carboplatin in Patients With Recurrent Glioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase I/II trial to study the effectiveness of pyrazoloacridine plus carboplatin in treating patients who have recurrent glioma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Detailed description

OBJECTIVES: I. Determine the maximum tolerated dose of pyrazoloacridine plus carboplatin in patients with recurrent glioma. II. Determine the toxic effects of this treatment regimen in these patients. III. Determine the safety of this treatment regimen at the recommended phase II dose in patients not receiving anticonvulsants. IV. Determine the efficacy of this treatment regimen in these patients. V. Assess the pharmacokinetics and metabolism of pyrazoloacridine in these patients. VI. Assess the response rate, time to progression, and time to death in patients treated with this regimen. OUTLINE: This is a three-part, dose-escalation, multicenter study. Patients in study 3 are stratified according to concurrent anticonvulsants (yes vs no). STUDY 1: (Study 1 closed as of 03/29/02) Patients receive carboplatin IV over 30 minutes and pyrazoloacridine IV over 3 hours on day 1. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of carboplatin and pyrazoloacridine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. STUDY 2: (Study 2 closed as of 03/29/02) Patients receive the same treatment as given in study 1. Dose escalation is performed as in study 1 to determine the MTD in patients not receiving concurrent anticonvulsants. STUDY 3: Patients receive the same treatment as given in studies 1 and 2 without dose escalation. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years. PROJECTED ACCRUAL: Study 1: A total of 3-21 patients will be accrued for this study within 6-20 months. Study 2: A total of 3-12 patients will be accrued for this study within 3-18 months. Study 3: A total of 12-37 patients will be accrued for this study within 15 months.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	pyrazoloacridine

Timeline

• Start date: 2000-05-01
• Primary completion: 2006-12-01
• Completion: 2007-04-01
• First posted: 2003-01-27
• Last updated: 2013-06-03

Locations

23 sites across 2 countries: United States, Canada