- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004245
Sodium Salicylate in Treating Patients With Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Chronic Lymphocytic Leukemia
A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Virginia Klimek, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- refractory anemia with excess blasts
- refractory anemia with excess blasts in transformation
- chronic myelomonocytic leukemia
- previously treated myelodysplastic syndromes
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with t(15;17)(q22;q12)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- recurrent adult acute myeloid leukemia
- untreated adult acute myeloid leukemia
- refractory chronic lymphocytic leukemia
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- atypical chronic myeloid leukemia, BCR-ABL1 negative
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Syndrome
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Preleukemia
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Salicylates
- Salicylsalicylic acid
- Sodium Salicylate
Other Study ID Numbers
- 99-057
- P30CA008748 (U.S. NIH Grant/Contract)
- MSKCC-99057
- NCI-G99-1661
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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