Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Oxaliplatin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	18 and over	NCI	NABTT-9902 JHOC-NABTT-9902, NCT00005856

Objectives

1. Determine the maximum tolerated dose of oxaliplatin in patients with newly diagnosed glioblastoma multiforme who are receiving or not receiving anticonvulsants known to be metabolized by P450.
2. Determine the dose-limiting toxicity and safety profile of this drug in this patient population.
3. Assess the pharmacokinetics of this drug on this schedule and determine the effects of P450-inducing anticonvulsants on the pharmacokinetics in these patients.
4. Determine the radiographic response rate in patients treated with this drug.
5. Determine survival and drug toxicity in these patients.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

• 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)

Chemotherapy:

• No prior chemotherapy for glioblastoma multiforme

Endocrine therapy:

• 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

Radiotherapy:

• No prior radiotherapy for glioblastoma multiforme

Surgery:

• See Disease Characteristics
• Recovered from immediate postoperative period

Other:

• At least 10 days since prior anticonvulsant drug that induces hepatic metabolic enzymes
• No other concurrent investigational agents

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 9.0 g/dL

Hepatic:

• Bilirubin normal

Renal:

• Creatinine normal

  OR

• Creatinine clearance at least 60 mL/min

Other:

• 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

Expected Enrollment

Approximately 24 patients (12 per stratum) will be accrued for the phase I part of this study within 8-12 months. A total of 18-35 patients will be accrued for the phase II part of this study within 5-12 months.

Outcomes

Maximum tolerated dose
Dose-limiting toxicity
Pharmacokinetics
Radiographic response rate

Survival
Toxicity

Outline

This is a phase I dose-escalation study of oxaliplatin followed by a phase II study. Patients are stratified according to whether concurrent anticonvulsant drugs induce P450 (yes vs modest/no or no drugs).

• Phase I: Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression.

  Cohorts of 3-6 patients (per stratum) receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.




• Phase II: Patients receive oxaliplatin as in phase I at the MTD determined in phase I.

Patients are followed at 1 month, every 2 months until disease progression, and then monthly thereafter.

Batchelor TT, Avgeropoulos NG., Supkso JG, et al.: Phase I/II trial of oxaliplatin in adults with newly diagnosed glioblastoma multiforme: NABTT 9902. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2100, 2002.

Trial Contact Information

Trial Lead Organizations

New Approaches to Brain Tumor Therapy

Tracy Batchelor, MD, MPH, Protocol chair		Ph: 617-643-1938; 877-726-5130

Registry Information
Official Title		Phase I/II Trial of Oxaliplatin as Neoadjuvant Treatment in Adults with Newly Diagnosed Glioblastoma Multiforme
Trial Start Date		2000-12-06
Registered in ClinicalTrials.gov		NCT00005856
Date Submitted to PDQ		2000-04-05
Information Last Verified		2007-10-14
NCI Grant/Contract Number		CA006973, CA062475

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