Oxaliplatin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

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

Summary

This phase I/II trial is studying the side effects and best dose of oxaliplatin in treating patients with newly diagnosed glioblastoma multiforme. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically confirmed supratentorial grade IV astrocytoma

• Glioblastoma multiforme

• Subtotal resection or biopsy with measurable and contrast-enhancing disease on the postoperative, pretreatment MRI/CT scan

• Performance status - Karnofsky 60-100%

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9.0 g/dL

• Bilirubin normal

• Creatinine normal

• Creatinine clearance at least 60 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No serious concurrent infection or medical illness that would jeopardize ability to receive protocol chemotherapy with reasonable safety

• No other prior malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer

• No grade 2 or greater pre-existing sensory neuropathy

• No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol chemotherapy

• Mini mental score at least 15

• No prior immunotherapy for glioblastoma multiforme

• No prior biologic therapy for glioblastoma multiforme, including:

• Immunotoxins

• Immunoconjugates

• Antiangiogenesis compounds

• Antisense

• Peptide receptor antagonists

• Interferons

• Interleukins

• Tumor infiltrating lymphocytes

• Lymphokine activated killer cells

• Gene therapy

• No concurrent filgrastim (G-CSF)

• No prior chemotherapy for glioblastoma multiforme

• No prior hormonal therapy for glioblastoma multiforme

• Prior glucocorticoid therapy for glioblastoma multiforme allowed

• Must be maintained on a stable (lowest required dose) corticosteroid regimen for at least 5 days before and during study

• No concurrent dexamethasone as an antiemetic

• No prior radiotherapy for glioblastoma multiforme

• Recovered from immediate postoperative period

• At least 10 days since prior anticonvulsant drug that induces hepatic metabolic enzymes

• No other concurrent investigational agents