Clinical trial NCT00004245: Sodium Salicylate in Treating Patients With Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Chronic Lymphocytic Leukemia
Official title: A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Keywords: recurrent adult acute myeloid leukemia
refractory chronic lymphocytic leukemia
untreated adult acute myeloid leukemia
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
chronic myelomonocytic leukemia
previously treated myelodysplastic syndromes
atypical chronic myeloid leukemia, BCR-ABL1 negative
myelodysplastic/myeloproliferative neoplasm, unclassifiable
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with t(15;17)(q22;q12)
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Virginia Klimek, MD
role: STUDY_CHAIR
References:
citation: 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.