Oxaliplatin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005856

Purpose

RATIONALE: 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.

PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin in treating patients with newly diagnosed glioblastoma multiforme.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: oxaliplatin	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I/II Trial of Oxaliplatin as Neoadjuvant Treatment in Adults With Newly Diagnosed Glioblastoma Multiforme

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Oxaliplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose [ Designated as safety issue: Yes ]
Dose-limiting toxicity [ Designated as safety issue: Yes ]
Pharmacokinetics [ Designated as safety issue: No ]
Radiographic response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	59
Study Start Date:	December 2000

Detailed Description:

OBJECTIVES:

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.
Determine the dose-limiting toxicity and safety profile of this drug in this patient population.
Assess the pharmacokinetics of this drug on this schedule and determine the effects of P450-inducing anticonvulsants on the pharmacokinetics in these patients.
Determine the radiographic response rate in patients treated with this drug.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 60-100%

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005856

Locations

United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Tracy Batchelor, MD, MPH

Massachusetts General Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000067883, NABTT-9902, JHOC-NABTT-9902
Study First Received:	June 2, 2000
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00005856 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Astrocytoma
Antineoplastic Agents
Nervous System Diseases
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Pharmacologic Actions
Neuroectodermal Tumors

Oxaliplatin
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009