Lobradimil and Carboplatin in Treating Children With Brain Tumors
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|ClinicalTrials.gov Identifier: NCT00019422|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 16, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: carboplatin Drug: lobradimil||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Trial of Intravenous Cereport (RMP-7) and Carboplatin in Childhood Brain Tumors|
|Study Start Date :||March 1998|
|Actual Study Completion Date :||April 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019422
|Study Chair:||Katherine Warren, MD||National Cancer Institute (NCI)|
|Study Chair:||Regina Jakacki, MD||University of Pittsburgh|