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Oxaliplatin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Primary Purpose

Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
oxaliplatin
pharmacological study
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Giant Cell Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New Approaches to Brain Tumor Therapy Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (oxaliplatin)

Arm Description

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.

Outcomes

Primary Outcome Measures

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)
DLT is defined as grade 3 or 4 nonhematological toxicities or hematological toxicities as assessed by CTC version 2.0 (Phase I)
Pharmacokinetics of oxaliplatin (Phase I)

Secondary Outcome Measures

Response rate (Phase II)
Duration of survival (Phase II)
Estimated with 95% confidence intervals.
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.

Full Information

First Posted
June 2, 2000
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005856
Brief Title
Oxaliplatin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Official Title
Phase I/II Trial of Oxaliplatin as Neoadjuvant Treatment in Adults With Newly Diagnosed Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
December 2000 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (oxaliplatin)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
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
Title
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
Title
Pharmacokinetics of oxaliplatin (Phase I)
Time Frame
At baseline, at immediately post infusion, at 2, 4, 22, and 24 hours (of course 1)
Secondary Outcome Measure Information:
Title
Response rate (Phase II)
Time Frame
Up to 7 years
Title
Duration of survival (Phase II)
Description
Estimated with 95% confidence intervals.
Time Frame
Up to 7 years
Title
Frequency of toxicity as assessed by CTC version 2.0 (Phase II)
Description
The proportion of patients with serious or life threatening toxicities will be estimated along with 95% confidence intervals.
Time Frame
Up to 7 years after completion of study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy Batchelor
Organizational Affiliation
New Approaches to Brain Tumor Therapy Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Approaches to Brain Tumor Therapy Consortium
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-1000
Country
United States

12. IPD Sharing Statement

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Oxaliplatin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

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