Sodium Salicylate in Treating Patients With Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Chronic Lymphocytic Leukemia

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00004245

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms	Drug: sodium salicylate	Phase 1

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia

Study Start Date :

Aug 1, 1999

Actual Primary Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Relapsed or refractory acute myelogenous leukemia OR
Elderly patients with newly diagnosed acute myelogenous leukemia not eligible for standard therapy OR
"High-risk" myelodysplastic syndrome, including:
Refractory anemia with excess blasts
Refractory anemia with excess blasts in transformation
Chronic myelomonocytic leukemia OR
Relapsed or refractory chronic lymphocytic leukemia
Not eligible for transplant protocols at MSKCC or refuses transplant
Not eligible for a higher priority protocol (e.g., bone marrow transplantation)

PATIENT CHARACTERISTICS:

Age:

Over 18

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Platelet count at least 25,000/mm^3

Hepatic:

Bilirubin no greater than 2.0 mg/dL
Transaminase levels less than 3 times upper limit of normal
PT no greater than 14 seconds
PTT no greater than 34.6 seconds

Renal:

Creatinine no greater than 2.0 mg/dL OR
Creatinine clearance greater than 60 mL/min

Other:

Not pregnant or nursing
No history of abnormal bleeding or unexplained bleeding disorders
No history of peptic ulcer disease
No salicylate allergy
No other concurrent active malignancy
No other concurrent illness that would preclude study assessment to a significant degree