Alanosine in Treating Patients With Cancer
- Conditions
- Lung CancerMalignant MesotheliomaPancreatic CancerSarcoma
- Registration Number
- NCT00062283
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Lynn Regional Cancer Center West
🇺🇸Boca Raton, Florida, United States
MD Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Wilshire Oncology Medical Group, Incorporated - La Verne
🇺🇸La Verne, California, 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
U.S. Oncology, Incorporated
🇺🇸Houston, Texas, United States