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| ID | Type | Description | Link |
|---|---|---|---|
| NYU-0004H | |||
| NYU-0029H | |||
| NCI-G00-1856 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | |||
| carboplatin | Drug | |||
| temozolomide | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed glioblastoma multiforme or anaplastic astrocytoma
Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan L. Finlay, MB, ChB | NYU Langone Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016190 | Carboplatin |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| D005910 |
| Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |