Viewing Study NCT00005602



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Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00005602
Status: COMPLETED
Last Update Posted: 2014-02-21
First Post: 2000-05-02

Brief Title: Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
Sponsor: Childrens Oncology Group
Organization: Childrens Oncology Group

Study Overview

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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CDR0000067715 OTHER ClinicalTrialsgov None
COG-ADVL0012 OTHER None None
CCG-ADVL0012 OTHER None None
ALK-01-042 None None None
CCG-09802 OTHER None None