Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed Over 18 NCI MSKCC-99057 NCI-G99-1661, NCT00004245

Objectives

1. 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.
2. Define biologic characteristics that influence the likelihood of a clinical response to this drug in this patient population.

Entry 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)

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Patient Characteristics:

Age:

• Over 18

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count at least 25,000/mm³

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

Expected Enrollment

A total of 20 patients will be accrued for this study within 1 year.

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Virginia Klimek, MD, Protocol chair		Ph: 212-639-6519; 800-525-2225

Registry Information
Official Title		A Phase I Study of Salicylate for Adult Patients with Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia
Trial Start Date		1999-08-24
Registered in ClinicalTrials.gov		NCT00004245
Date Submitted to PDQ		1999-12-27
Information Last Verified		2004-12-14
NCI Grant/Contract Number		P30-CA08748

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