Oxaliplatin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
|Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma||Drug: oxaliplatin Other: pharmacological study||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Oxaliplatin as Neoadjuvant Treatment in Adults With Newly Diagnosed Glioblastoma Multiforme|
- Maximum-tolerated dose (MTD) defined as the dose level at which 2 out of 6 or the dose level below that at which >= 2 of 3 or > 2 of 6 patients experience dose-limiting toxicity (DLT) assessed by Common Toxicity Criteria (CTC) version 2.0 (Phase I) [ Time Frame: 14 days ]
- DLT is defined as grade 3 or 4 nonhematological toxicities or hematological toxicities as assessed by CTC version 2.0 (Phase I) [ Time Frame: 14 days ]
- Pharmacokinetics of oxaliplatin (Phase I) [ Time Frame: At baseline, at immediately post infusion, at 2, 4, 22, and 24 hours (of course 1) ]
- Response rate (Phase II) [ Time Frame: Up to 7 years ]
- Duration of survival (Phase II) [ Time Frame: Up to 7 years ]Estimated with 95% confidence intervals.
- Frequency of toxicity as assessed by CTC version 2.0 (Phase II) [ Time Frame: Up to 7 years after completion of study treatment ]The proportion of patients with serious or life threatening toxicities will be estimated along with 95% confidence intervals.
|Study Start Date:||December 2000|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
Experimental: Treatment (oxaliplatin)
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression.
Other Names:Other: pharmacological study
Other Name: pharmacological studies
I. Determine the maximum tolerated dose of oxaliplatin in patients with newly diagnosed glioblastoma multiforme who are receiving or not receiving anticonvulsants known to be metabolized by P450.
II. Determine the dose-limiting toxicity and safety profile of this drug in this patient population.
III. Assess the pharmacokinetics of this drug on this schedule and determine the effects of P450-inducing anticonvulsants on the pharmacokinetics in these patients.
IV. Determine the radiographic response rate in patients treated with this drug.
V. Determine survival and drug toxicity in these patients.
OUTLINE: This is a phase I dose-escalation study of oxaliplatin followed by a phase II study. Patients are stratified according to whether concurrent anticonvulsant drugs induce P450 (yes vs modest/no or no drugs).
Phase I: Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients (per stratum) receive escalating doses of oxaliplatin 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.
Phase II: Patients receive oxaliplatin as in phase I at the MTD determined in phase I.
Patients are followed at 1 month, every 2 months until disease progression, and then monthly thereafter.
PROJECTED ACCRUAL: Approximately 24 patients (12 per stratum) will be accrued for the phase I part of this study within 8-12 months. A total of 18-35 patients will be accrued for the phase II part of this study within 5-12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005856
|United States, Maryland|
|New Approaches to Brain Tumor Therapy Consortium|
|Baltimore, Maryland, United States, 21231-1000|
|Principal Investigator:||Tracy Batchelor||New Approaches to Brain Tumor Therapy Consortium|