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


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Virginia Klimek, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-057

NCT ID:

NCT00004245

Start Date:

August 1999

Completion Date:

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021