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A Phase II Trial of Intravenous Cereport (RMP-7) and Carboplatin in Childhood Brain Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Lobradimil may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of carboplatin and lobradimil in treating children with brain tumors that have not responded to previous treatment.
OBJECTIVES: * Determine the objective response rate in patients with recurrent or refractory childhood brain tumors treated with lobradimil and carboplatin. * Determine the time to progression in patients treated with this regimen. * Assess the toxicity of this regimen in this patient population. * Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to histology (high-grade glioma vs low-grade glioma vs brainstem or visual pathway glioma vs medulloblastoma/primitive neuroectodermal tumor vs ependymoma). (Brainstem glioma stratum closed to accrual as of 12/21/2000.) (High-grade glioma stratum closed to accrual as of 01/08/2002.) Patients receive carboplatin IV over 15 minutes and lobradimil IV over 10 minutes on days 1 and 2. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 12, patients may receive additional courses at the discretion of the institutional investigator. Quality of life is assessed at baseline and then every 3 courses. Patients are followed every 3 months for 1 year or until evidence of disease progression or initiation of a new therapy. PROJECTED ACCRUAL: A maximum of 146 patients will be accrued for this study within 2-4 years.
Age
0 - 21 years
Sex
ALL
Healthy Volunteers
No
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
University of South Alabama Medical Center
Mobile, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center
Long Beach, California, United States
Start Date
March 1, 1998
Completion Date
April 1, 2003
Last Updated
August 16, 2013
carboplatin
DRUG
lobradimil
DRUG
Lead Sponsor
National Cancer Institute (NCI)
Collaborators
NCT00602667
NCT00683319
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07416188