Prinomastat Plus Temozolomide Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Back to Search
Print
Bookmark Trial

NCT00004200

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Agouron Pharmaceuticals, Inc.
La Jolla, California, 92037, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Brain and Central Nervous System Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16 + years

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Brain and Central Nervous System TumorsPrinomastat Plus Temozolomide Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme NCT00004200
  1. La Jolla, California
ALL GENDERS
16 Years+
years
MULTIPLE SITES
Brain and Central Nervous System TumorsLeflunomide in Treating Patients With Anaplastic Astrocytoma in First Relapse NCT00003775
  1. Phoenix, Arizona
  2. Los Angeles, California
  3. Denver, Colorado
  4. Miami Beach, Florida
  5. Chicago, Illinois
  6. Indianapolis, Indiana
  7. Iowa City, Iowa
  8. Boston, Massachusetts
  9. Ann Arbor, Michigan
  10. Detroit, Michigan
  11. Albany, New York
  12. Bronx, New York
  13. New York, New York
  14. New York, New York
  15. Chapel Hill, North Carolina
  16. Cincinnati, Ohio
  17. Columbus, Ohio
  18. Pittsburgh, Pennsylvania
  19. Providence, Rhode Island
  20. Dallas, Texas
  21. Houston, Texas
  22. Milwaukee, Wisconsin
  23. Edmonton, Alberta
  24. Vancouver, British Columbia
  25. London, Ontario
  26. Toronto, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Brain and Central Nervous System TumorsSU-101 Compared With Procarbazine in Treating Patients With Glioblastoma Multiforme NCT00003293
  1. Phoenix, Arizona
  2. Tucson, Arizona
  3. Los Angeles, California
  4. Los Angeles, California
  5. Los Angeles, California
  6. San Francisco, California
  7. Denver, Colorado
  8. Miami Beach, Florida
  9. Tampa, Florida
  10. Augusta, Georgia
  11. Chicago, Illinois
  12. Indianapolis, Indiana
  13. Iowa City, Iowa
  14. Boston, Massachusetts
  15. Worcester, Massachusetts
  16. Ann Arbor, Michigan
  17. Detroit, Michigan
  18. Omaha, Nebraska
  19. Albany, New York
  20. Bronx, New York
  21. New York, New York
  22. New York, New York
  23. Chapel Hill, North Carolina
  24. Cincinnati, Ohio
  25. Columbus, Ohio
  26. Pittsburgh, Pennsylvania
  27. Providence, Rhode Island
  28. Nashville, Tennessee
  29. Dallas, Texas
  30. Houston, Texas
  31. Seattle, Washington
  32. Milwaukee, Wisconsin
  33. Edmonton, Alberta
  34. London, Ontario
  35. Toronto, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Prinomastat Plus Temozolomide Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Drug: prinomastat
  • Drug: temozolomide
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004200
Other Study ID Numbers  ICMJE AG-3340-019
CDR0000067443
MCC-12151
MDA-DM-99254
MSKCC-99116
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair:Mary CollierAgouron Pharmaceuticals
PRS Account Pfizer
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP