NCT00004245

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2000

Completed
3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

5.1 years

First QC Date

January 28, 2000

Last Update Submit

January 17, 2013

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms

Keywords

recurrent adult acute myeloid leukemiarefractory chronic lymphocytic leukemiauntreated adult acute myeloid leukemiarefractory anemia with excess blastsrefractory anemia with excess blasts in transformationchronic myelomonocytic leukemiapreviously treated myelodysplastic syndromesatypical chronic myeloid leukemia, BCR-ABL1 negativemyelodysplastic/myeloproliferative neoplasm, unclassifiableadult 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) abnormalitiesadult acute myeloid leukemia with t(15;17)(q22;q12)

Interventions

sodium salicylateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related 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.

    PMID: 22154022RESULT

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesLeukemia, Myeloid, AcuteLeukemia, Lymphocytic, Chronic, B-CellAnemia, Refractory, with Excess of BlastsLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersCongenital Abnormalities

Interventions

Sodium Salicylate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLeukemia, MyeloidLeukemia, B-CellLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, RefractoryAnemiaCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Salicylic AcidSalicylatesHydroxybenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Virginia Klimek, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2000

First Posted

January 27, 2003

Study Start

August 1, 1999

Primary Completion

September 1, 2004

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

US(1)