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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004245 |
Purpose
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 |
|---|---|---|
|
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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000067491, MSKCC-99057, NCI-G99-1661 |
| Study First Received: | January 28, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004245 History of Changes |
| 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) |
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Anti-Inflammatory Agents Leukemia, Lymphoid Molecular Mechanisms of Pharmacological Action Precancerous Conditions Physiological Effects of Drugs Salicylates Sodium Salicylate Leukemia, Myeloid, Acute Leukemia Preleukemia Pathologic Processes Sensory System Agents Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Syndrome |
Anti-Inflammatory Agents, Non-Steroidal Analgesics Neoplasms by Histologic Type Immunoproliferative Disorders Disease Immune System Diseases Hematologic Diseases Cyclooxygenase Inhibitors Myelodysplastic Syndromes Salicylsalicylic acid Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Pharmacologic Actions Lymphatic Diseases |