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Sponsors and Collaborators: |
National Cancer Institute of Canada National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00392496 |
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 or refractory diffuse or mediastinal large B-cell lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: sunitinib malate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019), an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
Estimated Enrollment: | 25 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 25 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:
Histologically confirmed diffuse or mediastinal large B-cell lymphoma*, meeting the following criteria:
Bidimensionally measurable disease** by CT scan, MRI, or physical exam, with ≥ 1 disease site meeting 1 of the following criteria:
Received 1-2 prior chemotherapy regimens that included doxorubicin hydrochloride
One prior nonchemotherapy regimen in the form of radiation allowed
PATIENT CHARACTERISTICS:
None of the following in the past 12 months:
No other serious illness or medical condition that would preclude study participation, including, but not limited to, the following:
No condition that would impair the ability to swallow and retain sunitinib malate tablets, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 28 days since prior radiotherapy and recovered
At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
At least 7 days since prior and concurrent CYP3A4 inhibitors, including any of the following:
No prior therapy with other antiangiogenic agents or multitargeted tyrosine kinase inhibitors, including any of the following:
No concurrent therapeutic doses of coumarin-derivative anticoagulants (e.g., warfarin)
No concurrent agents with proarrhythmic potential, including any of the following:
Canada, Alberta | |
Cross Cancer Institute at University of Alberta | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Canada, British Columbia | |
BCCA - Fraser Valley Cancer Centre | |
Surrey, British Columbia, Canada, V3V 1Z2 | |
British Columbia Cancer Agency - Centre for the Southern Interior | |
Kelowna, British Columbia, Canada, V1Y 5L3 | |
Canada, Nova Scotia | |
Nova Scotia Cancer Centre | |
Halifax, Nova Scotia, Canada, B3H 1V7 | |
Canada, Ontario | |
Edmond Odette Cancer Centre at Sunnybrook | |
Toronto, Ontario, Canada, M4N 3M5 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Canada, Saskatchewan | |
Allan Blair Cancer Centre at Pasqua Hospital | |
Regina, Saskatchewan, Canada, S4T 7T1 |
Study Chair: | Rena Buckstein, MD | Edmond Odette Cancer Centre at Sunnybrook |
Responsible Party: | Cancer Research Institute at Queen's University ( Ralph M. Meyer ) |
Study ID Numbers: | CDR0000509173, CAN-NCIC-IND182 |
Study First Received: | October 25, 2006 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00392496 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma |
Lymphoma, B-Cell Lymphatic Diseases Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders B-cell Lymphomas Sunitinib |
Lymphoma, Large-cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Angiogenesis Inhibitors Lymphoma Recurrence |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors Pharmacologic Actions Lymphoma, B-Cell |
Lymphatic Diseases Neoplasms Sunitinib Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |