A Phase II Trial of Intravenous Cereport (RMP-7) and Carboplatin in Childhood Brain Tumors
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:
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.
DISEASE CHARACTERISTICS:
Histologically confirmed childhood brain tumor that is recurrent or refractory or for which no standard chemotherapy exists
Evidence of recurrent or progressive disease after front-line therapy documented as an increase in tumor size or appearance of new lesion(s) on MRI
Patients who did not previously receive radiotherapy as front-line therapy are eligible at time of second recurrence if the first recurrence was treated with radiotherapy only
Measurable disease in at least 2 dimensions by MRI
Disease must not be limited to the meninges
No metastases outside of the CNS
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Creatinine within limits as defined below by age:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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