Sunitinib in Treating Patients With Idiopathic Myelofibrosis
This phase II trial is studying how well sunitinib works in treating patients with idiopathic myelofibrosis. Sunitinib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the abnormal cells.
Accelerated Phase Chronic Myelogenous Leukemia
Acute Undifferentiated Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blastic Phase Chronic Myelogenous Leukemia
Chronic Myelomonocytic Leukemia
Chronic Phase Chronic Myelogenous Leukemia
Mast Cell Leukemia
Meningeal Chronic Myelogenous Leukemia
Progressive Hairy Cell Leukemia, Initial Treatment
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Relapsing Chronic Myelogenous Leukemia
Secondary Acute Myeloid Leukemia
Stage I Chronic Lymphocytic Leukemia
Stage II Chronic Lymphocytic Leukemia
Stage III Chronic Lymphocytic Leukemia
Stage IV Chronic Lymphocytic Leukemia
T-cell Large Granular Lymphocyte Leukemia
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Adult Acute Myeloid Leukemia
Untreated Hairy Cell Leukemia
Drug: sunitinib malate
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Sunitinib Malate in Idiopathic Myelofibrosis|
- Number of Participants With Objective Clinical Response to Sunitinib Therapy [ Time Frame: After two 6-week treatment courses (12 weeks) ] [ Designated as safety issue: No ]Participant response assessed after two cycles of therapy according to categories: 1) complete response, 2) partial response, 3) clinical improvement, 4) stable disease 5) progressive disease, 6) early death from malignant disease, 7) early death from toxicity, 8) early death because of other cause, or 9) unknown (not assessable, insufficient data).
|Study Start Date:||September 2006|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral sunitinib malate once daily for 6 weeks.
Drug: sunitinib malate
I. Assess the response rate and the duration of response in patients with idiopathic myelofibrosis treated with sunitinib malate.
I. Assess the safety of sunitinib malate in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral sunitinib malate once daily for 6 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Srdan Verstovsek||M.D. Anderson Cancer Center|