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Spots Global Cancer Trial Database for Leflunomide in Treating Patients With Anaplastic Astrocytoma in First Relapse

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Trial Identification

Brief Title: Leflunomide in Treating Patients With Anaplastic Astrocytoma in First Relapse

Official Title: A Phase II Open Label Study of SU101 for Patients With Anaplastic Astrocytoma in First Relapse

Study ID: NCT00003775

Interventions

leflunomide

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of leflunomide in treating patients who have anaplastic astrocytoma in first relapse.

Detailed Description: OBJECTIVES: I. Determine the median time to progression, median survival, and objective response of patients with anaplastic astrocytoma or anaplastic oligoastrocytoma in first relapse treated with intravenous leflunomide (SU101). II. Assess the safety of SU101 in these patients. III. Describe the health-related quality of life of patients treated with intravenous SU101. 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Albert Einstein Comprehensive Cancer Center, Bronx, 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

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

Contact Details

Name: Alison L. Hannah, MBBS

Affiliation: SUGEN

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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