Oxaliplatin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Stopped early · Phase 1/Phase 2
Conditions studied: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
In brief
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
Key facts
- Study ID
- NCT00005856
- Run by
- National Cancer Institute (NCI)
- People needed
- 59
- Starts
- 2000-12-01
- Last updated by the study team
- 2013-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- New Approaches to Brain Tumor Therapy Consortium — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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