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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 28, 2000 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | August 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004245 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Sodium Salicylate in Treating Patients With Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Chronic Lymphocytic Leukemia | ||||
| Official Title ICMJE | A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia | ||||
| 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: sodium salicylate | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004245 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067491, MSKCC-99057, NCI-G99-1661 | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | December 2004 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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