Oxaliplatin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

January 23, 2013 updated by: National Cancer Institute (NCI)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

I. 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.

II. Determine the dose-limiting toxicity and safety profile of this drug in this patient population.

III. Assess the pharmacokinetics of this drug on this schedule and determine the effects of P450-inducing anticonvulsants on the pharmacokinetics in these patients.

IV. Determine the radiographic response rate in patients treated with this drug.

V. Determine survival and drug toxicity in these patients.

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.

PROJECTED ACCRUAL: 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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231-1000
        • New Approaches to Brain Tumor Therapy Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (oxaliplatin)
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.
Drug: oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • L-OHP
Other: pharmacological study
Correlative studies
Other Names:
  • pharmacological studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: 14 days
14 days
DLT is defined as grade 3 or 4 nonhematological toxicities or hematological toxicities as assessed by CTC version 2.0 (Phase I)
Time Frame: 14 days
14 days
Pharmacokinetics of oxaliplatin (Phase I)
Time Frame: At baseline, at immediately post infusion, at 2, 4, 22, and 24 hours (of course 1)
At baseline, at immediately post infusion, at 2, 4, 22, and 24 hours (of course 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate (Phase II)
Time Frame: Up to 7 years
Up to 7 years
Duration of survival (Phase II)
Time Frame: Up to 7 years
Estimated with 95% confidence intervals.
Up to 7 years
Frequency of toxicity as assessed by CTC version 2.0 (Phase II)
Time Frame: Up to 7 years after completion of study treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Tracy Batchelor, New Approaches to Brain Tumor Therapy Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Primary Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

June 2, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02336
  • U01CA062475 (U.S. NIH Grant/Contract)
  • 9902
  • CDR0000067883 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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