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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


Phase 2
16 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Mary Collier

Investigator Role:

Study Chair

Investigator Affiliation:

Agouron Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

AG-3340-019

NCT ID:

NCT00004200

Start Date:

October 1999

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Agouron Pharmaceuticals, Inc.La Jolla, California  92037