Leukemia Clinical Trial
Official title:
A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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