SU-101 Compared With Procarbazine in Treating Patients With Glioblastoma Multiforme

NCT00003293

Last updated date
Study Location
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85001-2071, United States
Contact
1-800-718-1021

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
18 + 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]

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.

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 SU-101 Compared With Procarbazine in Treating Patients With Glioblastoma Multiforme
Official Title  ICMJE A Phase III Randomized Study of SU101 Versus Procarbazine for Patients With Glioblastoma Multiforme in First Relapse
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether SU-101 is more effective than procarbazine in treating patients with glioblastoma multiforme.

PURPOSE: Randomized phase III trial to compare the effectiveness of SU-101 with that of procarbazine in treating patients with glioblastoma multiforme that has recurred.

Detailed Description

OBJECTIVES: I. Compare the median survival of patients with glioblastoma multiforme in first relapse treated with intravenous leflunomide (SU101) administered as a loading dose with weekly maintenance therapy versus oral, single-agent procarbazine administered daily for 28 days every 56 days. II. Compare the median time to progression for these regimens in these patients. III. Assess the objective response of these patients. IV. Assess the safety of SU101 given on this schedule. V. Describe the health-related quality of life of these patients.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to performance status (Karnofsky 60-80% vs 90-100%), age (less than 50 vs 50 and over), and time from initial diagnosis to recurrence (6 months or greater vs less than 6 months). Patients are randomized to one of two treatment arms. Arm I: Patients receive leflunomide (SU101) IV over 6 hours daily on days 1-4, again 4-8 days later, and weekly thereafter for a total of 4 loading dose infusions and six maintenance infusions in course 1. Patients receive 7 weekly maintenance infusions of SU101 in courses thereafter. Treatment repeats every 8 weeks. Arm II: Patients receive procarbazine orally once or twice daily for 4 weeks. Treatment is repeated every 8 weeks. All patients complete a health-related quality-of-life questionnaire every 8 weeks and at study withdrawal. Treatment courses continue up to a maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients are followed every 2 months, beginning 30 days after study completion.

PROJECTED ACCRUAL: A maximum of 380 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Drug: leflunomide
  • Drug: procarbazine hydrochloride
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
Actual Study Completion Date  ICMJE May 2001
Actual Primary Completion Date May 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS: Histologically proven refractory or recurrent supratentorial glioblastoma multiforme Bidimensionally measurable, enhancing residual disease by T1-weighted gadolinium-enhanced MRI required within 15 days prior to treatment Stable dose of corticosteroids required for at least 7 days prior to scan

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 9 g/dL without blood transfusions for 15 days prior to treatment Hepatic: AST/SGOT no greater than 3 times upper limit of normal (ULN) Bilirubin less than 1.5 times ULN Renal: Creatinine no greater than 2 mg/dL OR Creatinine clearance at least 40 mL/min Other: Not allergic to etoposide Effective contraception required of fertile patients Negative serum pregnancy test required of fertile women No other acute or chronic medical or psychiatric condition

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior leflunomide (SU101) therapy No more than one prior single-agent or combination systemic chemotherapy regimen for initial disease Radiosensitizer(s) concurrent with radiotherapy allowed in addition to chemotherapy for primary disease At least 6 weeks since nitrosourea or mitomycin At least 2 weeks since vincristine No prior single-agent procarbazine At least 4 weeks since other chemotherapy No concurrent chemotherapy agents Endocrine therapy: No concurrent hormone therapy (except medroxyprogesterone acetate for appetite stimulation) Less than 4 weeks of prior hormonal therapy (tamoxifen or retinoids) if failed one prior chemotherapy regimen Radiotherapy: Prior conventional radiotherapy for initial disease required No more than one prior course of radiotherapy At least 8 weeks since radiotherapy No prior interstitial radiotherapy No concurrent radiotherapy Surgery: Maximally feasible resection for initial disease required No more than two resections permitted At least 1 week since surgery and/or biopsy for disease No prior interstitial radiotherapy or implanted BCNU-wafers No concurrent surgery (including resection, stereotactic surgery or interstitial implants) Other: No concurrent investigational agent At least 4 weeks since prior investigational agent At least 1 week since cholestyramine or monoamine oxidase inhibitors

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003293
Other Study ID Numbers  ICMJE SUGEN-SU101.015
CDR0000066226
MSKCC-98020
UCLA-HSPC-980105201
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:Alison L. Hannah, MBBSSUGEN
PRS Account Pfizer
Verification Date September 2012

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