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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004245 |
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.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: sodium salicylate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia |
Study Start Date: | August 1999 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
"High-risk" myelodysplastic syndrome, including:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Virginia Klimek, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000067491, MSKCC-99057, NCI-G99-1661 |
Study First Received: | January 28, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004245 |
Health Authority: | United States: Federal Government |
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 myelodysplastic/myeloproliferative disease, 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) |
Leukemia, Lymphoid Precancerous Conditions Chronic myelogenous leukemia Chronic myelomonocytic leukemia Refractory anemia Salicylates Sodium Salicylate Leukemia, Myeloid, Acute Leukemia Preleukemia Anemia, Refractory Leukemia, Lymphocytic, Chronic, B-Cell Acute myeloid leukemia, adult Congenital Abnormalities Acute myelocytic leukemia |
Chronic lymphocytic leukemia Myelodysplastic syndromes Immunoproliferative Disorders Hematologic Diseases Leukemia, B-cell, chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Salicylsalicylic acid Myelodysplasia Myelodysplastic Syndromes Acute myelogenous leukemia Anemia Myeloproliferative Disorders Leukemia, Myeloid Recurrence |
Anti-Inflammatory Agents Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Immune System Diseases Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Neoplasms |
Pathologic Processes Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Syndrome Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |