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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00003293
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Alison L. Hannah, MBBS
Principal Investigator Affiliation SUGEN
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors
Additional Details

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.#46;90-100%), age (less than 50 vs.#46;50 and over), and time from initial diagnosis to recurrence (6 months or greater vs.#46;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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

St. Joseph's Hospital and Medical Center, Phoenix, Arizona

Status

Address

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85001-2071

Arizona Cancer Center, Tucson, Arizona

Status

Address

Arizona Cancer Center

Tucson, Arizona, 85724

USC/Norris Comprehensive Cancer Center, Los Angeles, California

Status

Address

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800

Los Angeles, California

Status

Address

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781

Beckman Research Institute, City of Hope, Los Angeles, California

Status

Address

Beckman Research Institute, City of Hope

Los Angeles, California, 91010

St. Francis Hospital, San Francisco, California

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Address

St. Francis Hospital

San Francisco, California, 94109

University of Colorado Cancer Center, Denver, Colorado

Status

Address

University of Colorado Cancer Center

Denver, Colorado, 80262

Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida

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Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140

Tampa, Florida

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Address

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612

Augusta, Georgia

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Address

Medical College of Georgia Hospital and Clinics

Augusta, Georgia, 30912-3620

Chicago, Illinois

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Address

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611

Indiana University Cancer Center, Indianapolis, Indiana

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Address

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5265

University of Iowa College of Medicine, Iowa City, Iowa

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Address

University of Iowa College of Medicine

Iowa City, Iowa, 52242

Beth Israel Deaconess Medical Center, Boston, Massachusetts

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Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Worcester, Massachusetts

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Address

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655

Ann Arbor, Michigan

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Address

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752

Henry Ford Hospital, Detroit, Michigan

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Address

Henry Ford Hospital

Detroit, Michigan, 48202

University of Nebraska Medical Center, Omaha, Nebraska

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Address

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330

Cancer Center of Albany Medical Center, Albany, New York

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Address

Cancer Center of Albany Medical Center

Albany, New York, 12208

Bronx, New York

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Address

Albert Einstein Comprehensive Cancer Center

Bronx, New York, 10461

Memorial Sloan-Kettering Cancer Center, New York, New York

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Address

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021

New York, New York

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Address

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032

Chapel Hill, North Carolina

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Address

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295

Cincinnati, Ohio

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Address

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, 45219

Columbus, Ohio

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Address

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210

Western Pennsylvania Cancer Institute, Pittsburgh, Pennsylvania

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Address

Western Pennsylvania Cancer Institute

Pittsburgh, Pennsylvania, 15224

Rhode Island Hospital, Providence, Rhode Island

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Address

Rhode Island Hospital

Providence, Rhode Island, 02903

Vanderbilt Cancer Center, Nashville, Tennessee

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Address

Vanderbilt Cancer Center

Nashville, Tennessee, 37232-6838

Simmons Cancer Center - Dallas, Dallas, Texas

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Address

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154

Houston, Texas

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Address

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030

University of Washington Medical Center, Seattle, Washington

Status

Address

University of Washington Medical Center

Seattle, Washington, 98195-6043

Medical College of Wisconsin, Milwaukee, Wisconsin

Status

Address

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

International Sites

Cross Cancer Institute, Edmonton, Alberta, Canada

Status

Address

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2

London, Ontario, Canada

Status

Address

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6

Princess Margaret Hospital, Toronto, Ontario, Canada

Status

Address

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9