Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: filgrastim Drug: carboplatin Drug: temozolomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Temozolomide, Carboplatin and Neupogen in High-Grade Gliomas, Both Newly-Diagnosed and Recurrent |
| Study Start Date: | November 1997 |
OBJECTIVES:
- 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.
Eligibility| Ages Eligible for Study: | up to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed glioblastoma multiforme or anaplastic astrocytoma
- Residual tumor on postoperative MRI
- Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
- Under 65
Performance status:
- Karnofsky or Lansky 70-100% OR
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm^3
- Hemoglobin at least 8 g/dL (transfusion allowed)
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- SGPT no greater than 3 times ULN
Renal:
- Age 5 years and under: Creatinine less than 1.2 mg/dL
- Age over 5 to 10 years: Creatinine less than 1.5 mg/dL
- Age over 10 to 15 years: Creatinine less than 1.8 mg/dL
- Age over 15 years: Creatinine less than 2.4 mg/dL
Cardiovascular:
- No myocardial infarction within the past 6 months
Other:
- No other concurrent serious medical condition that would preclude study
- Able to tolerate oral medications
- No prior malignancy for which patient received prior chemotherapy or spinal irradiation
- No history of severe allergic reaction to platinum-containing compounds
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 72 hours since prior filgrastim (G-CSF)
Chemotherapy:
- No prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- Concurrent steroids for tumor-related cerebral edema allowed
- No concurrent corticosteroids for solely antiemetic purposes
Radiotherapy:
- No prior or concurrent radiotherapy
Surgery:
- Recovered from prior surgery
- No concurrent surgery
Contacts and Locations| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006263 History of Changes |
| Other Study ID Numbers: | CDR0000068203, NYU-0004H, NYU-0029H, NCI-G00-1856 |
| Study First Received: | September 11, 2000 |
| Last Updated: | January 14, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by New York University School of Medicine:
|
adult brain stem glioma adult glioblastoma childhood high-grade cerebral astrocytoma adult anaplastic astrocytoma |
adult anaplastic oligodendroglioma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Temozolomide |
Dacarbazine Carboplatin Lenograstim Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013