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Sponsors and Collaborators: |
Princess Margaret Hospital, Canada National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00451048 |
RATIONALE: Sunitinib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with myelodysplastic syndromes or chronic myelomonocytic leukemia.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes |
Drug: sunitinib malate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Sunitinib Malate (Sutent; SU11248) in Patients With Intermediate-2 or High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia |
Estimated Enrollment: | 32 |
Study Start Date: | February 2007 |
Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3-4 weeks and then monthly thereafter.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following diseases:
Myelodysplastic syndromes (MDS) meeting 1 of the following criteria:
Chronic myelomonocytic leukemia (CMML)
PATIENT CHARACTERISTICS:
No history of significant electrocardiogram abnormalities including, but not limited to, the following:
Ventricular arrhythmias
No NYHA class III-IV congestive heart failure
No serious cardiovascular disease within the past 12 months, including the following:
No condition that impairs the ability to swallow and retain sunitinib malate tablets, including the following:
PRIOR CONCURRENT THERAPY:
No other prior therapy for MDS or CMML except for epoetin alfa, darbepoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)
No other prior antiangiogenic agents including, but not limited to, the following:
More than 7 days since prior and no concurrent potent CYP3A4 inhibitors, including the following:
More than 12 days since prior and no concurrent potent CYP3A4 inducers, including the following:
No concurrent therapeutic coumarin-derivative anticoagulants (e.g., warfarin)
No concurrent agents with proarrhythmic potential, including the following:
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263-0001 | |
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 | |
Canada, Ontario | |
Edmond Odette Cancer Centre at Sunnybrook | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Contact: Rena Buckstein, MD 416-480-5847 rena.buckstein@sunnybrook.ca | |
London Regional Cancer Program at London Health Sciences Centre | Recruiting |
London, Ontario, Canada, N6A 465 | |
Contact: Kang Howson-Jan, MD 519-685-5194 Kang.howsonjan@lhsc.on.ca | |
McMaster Children's Hospital at Hamilton Health Sciences | Recruiting |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Contact: Brian Leber, MD, FRCPC 905-521-2100 ext. 76384 leberb@mcmaster.ca | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Karen W. L. Yee, MD 416-946-4495 karen.yee@uhn.on.ca |
Study Chair: | Karen W. L. Yee, MD | Princess Margaret Hospital, Canada |
Study ID Numbers: | CDR0000535656, PMH-PHL-063 |
Study First Received: | March 20, 2007 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00451048 |
Health Authority: | Unspecified |
de novo myelodysplastic syndromes secondary myelodysplastic syndromes chronic myelomonocytic leukemia |
Myelodysplastic syndromes Precancerous Conditions Chronic myelomonocytic leukemia Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplasia Myelodysplastic Syndromes Myeloproliferative Disorders Leukemia, Myeloid |
Leukemia, Myelomonocytic, Acute Myelodysplastic myeloproliferative disease Leukemia Preleukemia Sunitinib Neoplasm Metastasis Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases |
Neoplasms by Histologic Type Disease Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Pathologic Processes Syndrome Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |