cropped color_logo_with_background.png

Clinical Trial Finder

Oxaliplatin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00005856
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Tracy Batchelor
Principal Investigator Affiliation New Approaches to Brain Tumor Therapy Consortium
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
Additional Details

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.#46;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.

Arms & Interventions

Arms

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.

Interventions

Drug: - oxaliplatin

Given IV

Other: - pharmacological study

Correlative studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Baltimore, Maryland

Status

Address

New Approaches to Brain Tumor Therapy Consortium

Baltimore, Maryland, 21231-1000

Powered By