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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00514137 |
RATIONALE: Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with relapsed multiple myeloma.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: sunitinib malate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma |
Estimated Enrollment: | 35 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months for up to 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Measurable disease as defined by at least one of the following:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Any other condition, including the following:
NYHA class III or IV heart failure
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
No more than 4 prior therapies
Exclusion criteria:
At least 7 days since prior and no concurrent CYP3A4 inhibitors, including the following:
At least 12 days since prior and no concurrent CYP3A4 inducers, including the following:
Concurrent high-dose corticosteroids
Concurrent therapeutic doses of coumarin-derivative anticoagulants (e.g., warfarin)
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, District of Columbia | |
Howard University Cancer Center | |
Washington, District of Columbia, United States, 20060 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
Minnesota Oncology Hematology, PA - Minneapolis | |
Minneapolis, Minnesota, United States, 55407 | |
United States, Missouri | |
Center for Cancer Care and Research | |
Saint Louis, Missouri, United States, 63141 | |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
Saint Louis, Missouri, United States, 63110 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 | |
China | |
Prince of Wales Hospital | |
Hong Kong, China | |
Singapore | |
Cancer Institute at National University Hospital | |
Singapore, Singapore, 119074 | |
Johns Hopkins Singapore International Medical Centre | |
Singapore, Singapore, 308433 |
Study Chair: | Shaji K. Kumar, MD | Mayo Clinic |
Responsible Party: | Mayo Clinic Cancer Center ( Charles Erlichman ) |
Study ID Numbers: | CDR0000560703, MCCRC-MC058F |
Study First Received: | August 8, 2007 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00514137 History of Changes |
Health Authority: | United States: Food and Drug Administration |
refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Angiogenesis Inhibitors Multiple Myeloma Hemorrhagic Disorders Sunitinib Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Blood Protein Disorders Hematologic Diseases Growth Substances Physiological Effects of Drugs Vascular Diseases Paraproteinemias Hemostatic Disorders Angiogenesis Inhibitors |
Pharmacologic Actions Multiple Myeloma Neoplasms Hemorrhagic Disorders Sunitinib Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Lymphoproliferative Disorders Neoplasms, Plasma Cell |