Adult Glioblastoma Clinical Trial
Official title:
Phase I/II Trial of Oxaliplatin as Neoadjuvant Treatment in Adults With Newly Diagnosed Glioblastoma Multiforme
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
Status | Terminated |
Enrollment | 59 |
Est. completion date | |
Est. primary completion date | January 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | New Approaches to Brain Tumor Therapy Consortium | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum-tolerated dose (MTD) defined as the dose level at which 2 out of 6 or the dose level below that at which >= 2 of 3 or > 2 of 6 patients experience dose-limiting toxicity (DLT) assessed by Common Toxicity Criteria (CTC) version 2.0 (Phase I) | 14 days | Yes | |
Primary | DLT is defined as grade 3 or 4 nonhematological toxicities or hematological toxicities as assessed by CTC version 2.0 (Phase I) | 14 days | Yes | |
Primary | Pharmacokinetics of oxaliplatin (Phase I) | At baseline, at immediately post infusion, at 2, 4, 22, and 24 hours (of course 1) | No | |
Secondary | Response rate (Phase II) | Up to 7 years | No | |
Secondary | Duration of survival (Phase II) | Estimated with 95% confidence intervals. | Up to 7 years | No |
Secondary | Frequency of toxicity as assessed by CTC version 2.0 (Phase II) | The proportion of patients with serious or life threatening toxicities will be estimated along with 95% confidence intervals. | Up to 7 years after completion of study treatment | Yes |
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