A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia
- 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.
Masking: Open Label, Primary Purpose: Treatment
Virginia Klimek, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|