Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
|ClinicalTrials.gov Identifier: NCT00006263|
Recruitment Status : Withdrawn
First Posted : January 27, 2003
Last Update Posted : August 5, 2015
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining carboplatin, temozolomide, and filgrastim in treating patients who have newly diagnosed or recurrent high-grade glioma.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Biological: filgrastim Drug: carboplatin Drug: temozolomide||Phase 2|
- Determine the response rate in patients with newly diagnosed high-grade glioma treated with temozolomide, carboplatin, and filgrastim (G-CSF).
- Determine the toxicity of this treatment regimen in these patients.
- Determine the rate of tumor progression in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to disease category (glioblastoma multiforme vs anaplastic astrocytoma vs several other high-grade mixed gliomas).
Patients receive carboplatin IV over 4 hours on days 1-2; oral temozolomide every 12 hours on days 1-5; and filgrastim (G-CSF) subcutaneously or IV daily starting no earlier than day 7 and continuing until blood counts recover. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 102-222 (17-37 per each of 6 strata) will be accrued for this study within 4 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Official Title:||Phase II Trial of Temozolomide, Carboplatin and Neupogen in High-Grade Gliomas, Both Newly-Diagnosed and Recurrent|
|Study Start Date :||November 1997|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006263
|United States, New York|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Study Chair:||Jonathan L. Finlay, MB, ChB||New York University School of Medicine|