Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase II Trial of Intravenous Cereport (RMP-7) and Carboplatin in Childhood Brain Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Lobradimil may increase the effectiveness of a chemotherapy
drug by making tumor cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of carboplatin and lobradimil in treating
children with brain tumors that have not responded to previous treatment.
OBJECTIVES:
- Determine the objective response rate in patients with recurrent or refractory
childhood brain tumors treated with lobradimil and carboplatin.
- Determine the time to progression in patients treated with this regimen.
- Assess the toxicity of this regimen in this patient population.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients are stratified according to histology (high-grade glioma vs low-grade glioma vs
brainstem or visual pathway glioma vs medulloblastoma/primitive neuroectodermal tumor vs
ependymoma). (Brainstem glioma stratum closed to accrual as of 12/21/2000.) (High-grade
glioma stratum closed to accrual as of 01/08/2002.)
Patients receive carboplatin IV over 15 minutes and lobradimil IV over 10 minutes on days 1
and 2. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease
progression or unacceptable toxicity. After completion of course 12, patients may receive
additional courses at the discretion of the institutional investigator.
Quality of life is assessed at baseline and then every 3 courses.
Patients are followed every 3 months for 1 year or until evidence of disease progression or
initiation of a new therapy.
PROJECTED ACCRUAL: A maximum of 146 patients will be accrued for this study within 2-4
years.
;
Primary Purpose: Treatment
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