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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004245
• Other study ID #: 99-057
• Secondary ID: P30CA008748MSKCC
• Status: Completed
• Phase: Phase 1
• First received: January 28, 2000
• Last updated: January 17, 2013
• Start date: August 1999

Study information

• Verified date: January 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Preleukemia

Intervention

Drug:
• sodium salicylate

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Klimek VM, Dolezal EK, Smith L, Soff G, Nimer SD. Phase I trial of sodium salicylate in patients with myelodysplastic syndromes and acute myelogenous leukemia. Leuk Res. 2012 May;36(5):570-4. doi: 10.1016/j.leukres.2011.10.023. Epub 2011 Dec 9. — View Citation