Alanosine in Treating Patients With Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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 Start Date:||March 2003|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062283
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, Arizona|
|Arizona Cancer Center at University of Arizona Health Sciences Center|
|Tucson, Arizona, United States, 85724|
|United States, California|
|Wilshire Oncology Medical Group, Incorporated - La Verne|
|La Verne, California, United States, 91750|
|Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Florida|
|Lynn Regional Cancer Center West|
|Boca Raton, Florida, United States, 33428|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Midwest Cancer Research Group, Incorporated|
|Skokie, Illinois, United States, 60077|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|St. Vincent's Comprehensive Cancer Center - Manhattan|
|New York, New York, United States, 10011|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center|
|Nashville, Tennessee, United States, 37232-6838|
|United States, Texas|
|MD Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030|
|U.S. Oncology, Incorporated|
|Houston, Texas, United States, 77060|
|Study Chair:||Paul A. Meyers, MD||Memorial Sloan-Kettering Cancer Center|