Trials / Completed
CompletedNCT00004245
Sodium Salicylate in Treating Patients With Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Chronic Lymphocytic Leukemia
A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of sodium salicylate in treating patients who have advanced myelodysplastic syndrome , acute myelogenous leukemia or chronic lymphocytic leukemia.
Detailed description
OBJECTIVES: * Evaluate the safety, toxicity, and pharmacokinetics of sodium salicylate in patients with advanced myelodysplastic syndrome; newly diagnosed, relapsed, or refractory acute myelogenous leukemia; or relapsed or refractory chronic lymphocytic leukemia. * Define biologic characteristics that influence the likelihood of a clinical response to this drug in this patient population. OUTLINE: Patients receive oral sodium salicylate twice a day. Intrapatient dose escalation or de-escalation is permitted. Treatment continues for up to 6 weeks in the absence of unacceptable toxicity or disease progression. Responding patients may continue to receive sodium salicylate beyond the 6-week period. Patients with acute myelogenous leukemia are followed until the end of therapy. Patients with myelodysplastic syndrome are followed until death or progression to leukemia. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 1 year.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sodium salicylate |
Timeline
- Start date
- 1999-08-01
- Primary completion
- 2004-09-01
- First posted
- 2003-01-27
- Last updated
- 2013-01-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00004245. Inclusion in this directory is not an endorsement.