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| Sponsored by: |
Agouron Pharmaceuticals |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004200 |
Purpose
RATIONALE: Prinomastat may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. Drugs used in chemotherapy stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase II trial to study the effectiveness of prinomastat plus temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: prinomastat Drug: temozolomide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | A Randomized Double-Blind, Placebo-Controlled Phase II Study of the Matrix Metalloprotease Inhibitor Prinomastat in Combination With Temozolomide Following Radiation Therapy in Patients Having Newly Diagnosed Glioblastoma Multiforme |
| Study Start Date: | October 1999 |
OBJECTIVES: I. Compare the one year survival rate and progression free survival of patients with newly diagnosed glioblastoma multiforme treated with prinomastat (AG3340) or placebo and temozolomide following radiotherapy. II. Compare the safety of these regimens in these patients. III. Compare the quality of life in these patients on these regimens.
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Newly diagnosed glioblastoma multiforme Must have completed all appropriate subtotal or total surgical procedures (surgical biopsy alone not eligible) Must have received prior external beam radiotherapy No multifocal glioblastoma multiforme No radiographic disease progression during post surgical radiotherapy
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic:
Not specified Renal: Not specified
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
Contacts and Locations| United States, California | |
| Agouron Pharmaceuticals, Inc. | |
| La Jolla, California, United States, 92037 | |
| Study Chair: | Mary Collier | Agouron Pharmaceuticals |
More Information
| Study ID Numbers: | CDR0000067443, AG-3340-019, MCC-12151, MDA-DM-99254, MSKCC-99116 |
| Study First Received: | January 21, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004200 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
|
Glioblastoma Astrocytoma Central Nervous System Neoplasms Temozolomide Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Glioma Glioblastoma Multiforme Antineoplastic Agents, Alkylating Gliosarcoma Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
|
Glioblastoma Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Astrocytoma Antineoplastic Agents Nervous System Diseases Neoplasms, Nerve Tissue Central Nervous System Neoplasms Temozolomide Pharmacologic Actions Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Antineoplastic Agents, Alkylating Glioma Neoplasms, Neuroepithelial Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
