Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as
carboplatin and lobradimil may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with
carboplatin and lobradimil in treating children who have newly diagnosed brain stem gliomas.
OBJECTIVES:
- Determine the maximum tolerated duration of lobradimil plus carboplatin with
radiotherapy in patients with newly diagnosed brain stem gliomas.
- Determine the toxic effects of this treatment regimen in these patients.
- Assess the response to radiotherapy in patients treated with this regimen.
OUTLINE: Patients receive radiotherapy for 5 consecutive days a week for 6.5 weeks, for a
total of 33 doses. Patients receive carboplatin IV over 15 minutes followed by lobradimil IV
over 10 minutes concurrently with radiotherapy.
The first cohort of 3-6 patients receives treatment with carboplatin and lobradimil for the
first three weeks of radiotherapy, with the duration of chemotherapy increasing by one week
with each subsequent cohort until the maximum duration of 6.5 weeks is reached or until
unacceptable toxicity occurs in 2 of 6 patients.
Patients are followed at 6 weeks; every 3 months for 2 years; every 6 months for 3 years;
and then annually thereafter.
PROJECTED ACCRUAL: A total of 15-24 patients will be accrued for this study within 36
months.
;
Primary Purpose: Treatment
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