Prinomastat Plus Temozolomide Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT ID: NCT00004200
Last Updated: 2012-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1999-10-31
Brief Summary
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PURPOSE: Randomized phase II trial to study the effectiveness of prinomastat plus temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.
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Detailed Description
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OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients receive oral prinomastat or placebo twice daily in combination with oral temozolomide daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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prinomastat
temozolomide
Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Stable steroid therapy for at least 2 weeks prior to study Radiotherapy: See Disease Characteristics No prior interstitial brachytherapy or radiosurgery Surgery: See Disease Characteristics No prior radiosurgery
16 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Mary Collier
Role: STUDY_CHAIR
Agouron Pharmaceuticals
Locations
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Agouron Pharmaceuticals, Inc.
La Jolla, California, United States
Countries
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Other Identifiers
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CDR0000067443
Identifier Type: -
Identifier Source: secondary_id
MCC-12151
Identifier Type: -
Identifier Source: secondary_id
MDA-DM-99254
Identifier Type: -
Identifier Source: secondary_id
MSKCC-99116
Identifier Type: -
Identifier Source: secondary_id
AG-3340-019
Identifier Type: -
Identifier Source: org_study_id
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