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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Dacarbazine; Lenograstim; Temozolomide

Criteria

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