Official Title: Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas
Status: COMPLETED
Status Verified Date: 2014-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 65 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 65 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