Phase I Study of Concurrent Cereport and Carboplatin With Radiation Therapy for Children With Newly-Diagnosed Brain Stem Gliomas
- 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
Primary Purpose: Treatment
Roger J. Packer, MD
Children's Research Institute
United States: Federal Government
|Baylor College of Medicine||Houston, Texas 77030|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|University of Mississippi Medical Center||Jackson, Mississippi 39216-4505|
|State University of New York - Upstate Medical University||Syracuse, New York 13210|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|MBCCOP - LSU Health Sciences Center||New Orleans, Louisiana 70112|
|Herbert Irving Comprehensive Cancer Center||New York, New York 10032|
|Children's Hospital Los Angeles||Los Angeles, California 90027-0700|
|Children's National Medical Center||Washington, District of Columbia 20010-2970|
|Children's Hospital Medical Center - Cincinnati||Cincinnati, Ohio 45229-3039|
|Doernbecher Children's Hospital||Portland, Oregon 97201-3098|
|Children's Hospital of Pittsburgh||Pittsburgh, Pennsylvania 15213|
|Children's Hospital and Regional Medical Center - Seattle||Seattle, Washington 98105|
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|
|Albert Einstein Clinical Cancer Center||Bronx, New York 10461|
|Lucile Packard Children's Hospital at Stanford||Palo Alto, California 94304|