Sodium Salicylate in Treating Patients With Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Chronic Lymphocytic Leukemia
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00004245
First received: January 28, 2000
Last updated: January 17, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Neoplasms |
Drug: sodium salicylate |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia |
Resource links provided by NLM:
MedlinePlus related topics:
Acute Myeloid Leukemia
Anemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Leukemia
Myelodysplastic Syndromes
U.S. FDA Resources
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
| Study Start Date: | August 1999 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004245
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Study Chair: | Virginia Klimek, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00004245 History of Changes |
| Other Study ID Numbers: | 99-057, P30CA008748, MSKCC-99057, NCI-G99-1661 |
| Study First Received: | January 28, 2000 |
| Last Updated: | January 17, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
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) |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Neoplasms by Histologic Type Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Salicylates Sodium Salicylate Salicylsalicylic acid Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 17, 2013