Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas

Phase 1

Completed

• Conditions: Brain and Central Nervous System Tumors
• Interventions: Drug: carboplatin; Drug: cereport; Radiation: radiation therapy

• Registration Number: NCT00005602
• Lead Sponsor: Children's Oncology Group

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 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.

Study Timeline

• Study First Submitted: 2000-05-02
• Study Start: 2001-02
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-01
• Study Completion: 2005-09
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-19
• Last Update Posted: 2014-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days	carboplatin	-
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days	cereport	-
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days	cereport	-
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days	radiation therapy	-
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 25 Days	radiation therapy	-
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days	carboplatin	-
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days	cereport	-
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 30 Days	radiation therapy	-
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days	carboplatin	-
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days	cereport	-
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 33 Days	radiation therapy	-
Radiation Therapy, 33 Doses; Carboplatin 35mg^m2 for 20 Days	carboplatin	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival		A MRI scan will be performed six (6) weeks after completion of radiation, plus at three-month intervals thereafter for two years, as long as there is no evidence of progressive disease. Children who are progression-free two years after treatment will have MRI scanning at six-month intervals, thereafter, for three more years

Trial Locations

Locations (19)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Lucile Packard Children's Hospital at Stanford; 🇺🇸 Palo Alto, California, United States

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

MBCCOP - LSU Health Sciences Center; 🇺🇸 New Orleans, Louisiana, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Albert Einstein Clinical Cancer Center; 🇺🇸 Bronx, New York, United States

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