Leflunomide in Treating Patients With Anaplastic Astrocytoma in First Relapse
NCT ID: NCT00003775
Last Updated: 2012-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
1998-12-31
2006-05-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of leflunomide in treating patients who have anaplastic astrocytoma in first relapse.
Detailed Description
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OUTLINE: This is an open label, multicenter study. Patients receive leflunomide (SU101) IV over 6 hours on days 1-4. Patients then receive SU101 IV over 6 hours weekly for 6 weeks (beginning between days 8-12). Patients exhibiting complete response, partial response, or stable disease may continue on treatment for up to a year or until disease progression or unacceptable toxicity occurs. Patients continuing therapy receive SU101 IV over 6 hours every week for 7 weeks, followed by 1 week of rest. Quality of life is assessed every 8 weeks and at the end of the study. Patients are followed every 8 weeks or until tumor progression.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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leflunomide
Eligibility Criteria
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Inclusion Criteria
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 Hepatic: AST 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 pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after the study No known allergy to etoposide No other acute or chronic medical illness or psychiatric disorder
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) and recovered No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (2 weeks since vincristine; 6 weeks since nitrosoureas or mitomycin) and recovered No prior leflunomide (SU101) therapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy (except medroxyprogesterone acetate for appetite stimulation) Radiotherapy: See Disease Characteristics No more than 1 prior course of radiotherapy At least 8 weeks since prior radiotherapy and recovered No prior interstitial radiotherapy or implanted carmustine wafers Prior radiosensitizer(s) concurrent with radiotherapy or used as neoadjuvant therapy allowed No concurrent radiotherapy Surgery: See Disease Characteristics No more than 2 prior surgical resections At least 1 week since prior surgery or biopsy for anaplastic astrocytoma No concurrent surgery (including resection, stereotactic surgery, or interstitial implants) Other: At least 4 weeks since prior investigational agents No other concurrent investigational agents
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Alison L. Hannah, MBBS
Role: STUDY_CHAIR
SUGEN
Locations
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St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University of Iowa College of Medicine
Iowa City, Iowa, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Cancer Center of Albany Medical Center
Albany, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Neurological Institute
New York, New York, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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CDR0000066904
Identifier Type: -
Identifier Source: secondary_id
MSKCC-98111
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1506
Identifier Type: -
Identifier Source: secondary_id
SUGEN-SU101.021
Identifier Type: -
Identifier Source: org_study_id