Spots Global Cancer Trial Database for Alanosine in Treating Patients With Cancer
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Trial Identification
Brief Title: Alanosine in Treating Patients With Cancer
Official Title: A Phase II, Open-Label, Non-Randomized, Multicenter, Single Agent Study of Intravenous SDX-102 for the Treatment of Patients With MTAP-Deficient Cancer
Study ID: NCT00062283
Interventions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy such as alanosine use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well alanosine works in treating patients with soft tissue sarcoma, sarcoma of the bone, mesothelioma, non-small cell lung cancer, or pancreatic cancer.
Detailed Description: OBJECTIVES: * Determine the response rates in patients with methylthioadenosine phosphorylase (MTAP)-deficient cancer when treated with alanosine. * Determine the time to response and duration of response in patients treated with this drug. * Determine the progression-free survival of patients treated with this drug. * Determine the pharmacodynamic activity of this drug in these patients, based on special imaging to measure tumor adenosine triphosphate depletion. * Determine the pharmacokinetic activity of this drug in these patients. * Determine the safety and tolerability of this drug in these patients. OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive alanosine IV continuously on days 1-5. Treatment repeats every 21 days for up to 9 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days. PROJECTED ACCRUAL: A total of 50-145 patients (10-29 per tumor type) will be accrued for this study.
Keywords
Eligibility
Minimum Age: 13 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, United States
Wilshire Oncology Medical Group, Incorporated - La Verne, La Verne, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles, California, United States
Lynn Regional Cancer Center West, Boca Raton, Florida, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Midwest Cancer Research Group, Incorporated, Skokie, Illinois, United States
St. Vincent's Comprehensive Cancer Center - Manhattan, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, United States
MD Anderson Cancer Center at University of Texas, Houston, Texas, United States
U.S. Oncology, Incorporated, Houston, Texas, United States
Contact Details
Name: Paul A. Meyers, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR
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