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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00095784 |
RATIONALE: Drugs used in chemotherapy, such as decitabine, work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well decitabine works in treating patients with myelofibrosis.
Condition | Intervention | Phase |
---|---|---|
Chronic Myeloproliferative Disorders |
Drug: decitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Decitabine in Myelofibrosis |
Estimated Enrollment: | 20 |
Study Start Date: | September 2004 |
Estimated Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive decitabine subcutaneously on days 1-5 and 8-12. Treatment repeats every 42 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 10 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed myeloid metaplasia with myelofibrosis (MMM), including all of the following subtypes:
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Illinois | |
Central Illinois Hematology Oncology Center | Recruiting |
Springfield, Illinois, United States, 62701 | |
Contact: Edem S. Agamah, MD, MS 217-525-2500 ihdn@aol.com | |
Decatur Memorial Hospital Cancer Care Institute | Recruiting |
Decatur, Illinois, United States, 62526 | |
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care 217-876-6601 | |
Evanston Northwestern Healthcare - Evanston Hospital | Recruiting |
Evanston, Illinois, United States, 60201-1781 | |
Contact: Clinical Trials Office - Evanston Northwestern Healthcare - Ev 847-570-1381 | |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Recruiting |
Harvey, Illinois, United States, 60426 | |
Contact: Clinical Trials Office - Ingalls Cancer Care Center at Ingalls 708-915-6747 | |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Recruiting |
Peoria, Illinois, United States, 61615-7828 | |
Contact: John W. Kugler, MD 309-243-3605 jkugler@ohaci.com | |
Simmons Cooper Cancer Institute | Recruiting |
Springfield, Illinois, United States, 62794-9677 | |
Contact: Clinical Trials Office - Simmons Cooper Cancer Institute 217-545-7929 | |
University of Chicago Cancer Research Center | Recruiting |
Chicago, Illinois, United States, 60637-1470 | |
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | Recruiting |
South Bend, Indiana, United States, 46601 | |
Contact: David A. Taber, MD 574-647-3353 | |
Fort Wayne Medical Oncology and Hematology | Recruiting |
Fort Wayne, Indiana, United States, 46885-5099 | |
Contact: David F. Sciortino, MD 260-484-8830 | |
United States, Michigan | |
Oncology Care Associates, PLLC | Recruiting |
Saint Joseph, Michigan, United States, 49085 | |
Contact: Eric P. Lester, MD 269-985-0029 | |
United States, Wisconsin | |
Medical College of Wisconsin Cancer Center | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380 |
Principal Investigator: | Olatoyosi M. Odenike, MD | University of Chicago |
Study ID Numbers: | CDR0000393839, UCCRC-13327A, NCI-6814 |
Study First Received: | November 9, 2004 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00095784 |
Health Authority: | Unspecified |
chronic idiopathic myelofibrosis |
Myeloid Metaplasia Myelofibrosis-osteosclerosis Lymphatic Diseases Myelofibrosis Hematologic Diseases |
Metaplasia Chronic Myeloproliferative Disorders Myeloproliferative Disorders Decitabine Bone Marrow Diseases |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Splenic Diseases Pharmacologic Actions |