Trials / Completed
CompletedNCT00062283
Alanosine in Treating Patients With Cancer
A Phase II, Open-Label, Non-Randomized, Multicenter, Single Agent Study of Intravenous SDX-102 for the Treatment of Patients With MTAP-Deficient Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 13 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | L-alanosine |
Timeline
- Start date
- 2003-03-01
- Primary completion
- 2005-12-01
- Completion
- 2009-12-01
- First posted
- 2003-06-06
- Last updated
- 2013-06-26
Locations
12 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00062283. Inclusion in this directory is not an endorsement.