Spots Global Cancer Trial Database for Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
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Trial Identification
Brief Title: Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
Official Title: Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas
Study ID: NCT00005602
Conditions
Study Description
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.
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
State University of New York - Upstate Medical University, Syracuse, New York, United States
Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio, United States
Doernbecher Children's Hospital, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
Contact Details
Name: Roger J. Packer, MD
Affiliation: Children's National Research Institute
Role: STUDY_CHAIR
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