Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma

Sponsor

NYU Langone Health (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00006263

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Study Details

Study Description

Brief Summary

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

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

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 :

Nov 1, 1997

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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