This study will examine the response rate and the 6-month progression-free survival rates of subjects with advanced sarcoma treated with dasatinib.
Further details provided by SARC (Sarcoma Alliance for Research through Collaboration): Treatment: Subjects take Dasatinib twice daily by mouth for 28 days per 28 day cycle. Subjects will be seen for interim medical history, physical exam and laboratory studies prior to each cycle. Subjects will undergo tumor imaging every 2 months (8 weeks) for the first 6 months and approximately every 3 months thereafter while on treatment. A blood sample for collection of specimens with which to later study serum level of Dasatinib and effects on biomarkers of drug activity will be obtained approximately 2 to 4 weeks after the start of treatment. Central collection of archival tumor with which to later study the frequency of expression and/or mutation of kinases inhibited by dasatinib will occur. Subjects will be followed for approximately every 3 months until 2 years from registration and then approximately yearly until 5 years from registration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
366
oral agent, continuous dosing, Cycles = 28 days
Arkansas Children's Hospital
Little Rock, Arkansas, United States
City of Hope
Duarte, California, United States
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States
Kootenai Cancer Center
Coeur d'Alene, Idaho, United States
Oncology Specialists
Park Ridge, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
...and 10 more locations
Response Rate: Number of Participants With Objective Tumor Response
Assessment of objective tumor response for response rate with MRI or CT using Choi criteria: Complete Remission (CR) Complete disappearance of all measurable and evaluable disease for at least 4 weeks; Partial Remission (PR) A 10% or greater decrease from the baseline in the sum of the largest diameters of all measurable target lesions.
Time frame: Up to 24 months
6 Month Progression-free Survival Rate of "Indolent" Sarcomas Treated With Dasatinib
Estimate the 6 month progression-free survival rate of "indolent" sarcomas treated with dasatinib. Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass.
Time frame: At 6 months
6 Month Progression-free Survival Rate of Gastrointestinal Stromal Tumors (GIST)
To estimate the 6 month progression-free survival rate of gastrointestinal stromal tumors (GIST). Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass.
Time frame: 6 months
Median Time-to-progression of Subjects With GIST Treated With Dasatinib.
To estimate the median time-to-progression of subjects with GIST treated with dasatinib.
Time frame: Up to 30 months
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib.
To estimate the overall survival rates at 2 and 5 years from registration of subjects treated with dasatinib.
Time frame: At 2 and 5 years
Median Time-to-progression of Subjects With "Indolent" Sarcomas Treated With Dasatinib.
To estimate the median time-to-progression of subjects with "indolent" sarcomas treated with dasatinib.
Time frame: Up to 24 months
6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.
To estimate the 6 month progression-free survival rate of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, Malignant fibrous histiocytoma (MFH), rhabdomyosarcoma and MPNST treated with dasatinib.
Time frame: At 6 months
Median Time-to-progression of Subjects Enrolled in the Aggressive Subtype.
To estimate the median time-to-progression of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, MFH, rhabdomyosarcoma and MPNST treated with dasatinib.
Time frame: Up to 37 weeks
Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
To estimate the overall survival rates at 2 and 5 years from registration of subjects enrolled in the aggressive subtype treated with dasatinib.
Time frame: At 2 and 5 years
Uni-dimensional and Bi-dimensional Tumor Size, Tumor Volumes and Tumor Average Density Determined by Computer-aided Automated Detection in a Subset of Subjects With Tumor Predominately Involving the Lung
To prospectively collect uni-dimensional and bi-dimensional tumor size, tumor volumes and tumor average density determined by computer-aided automated detection in a subset of subjects with tumor predominately involving the lung
Time frame: Up to 37 weeks
Plasma Level of Dasatinib and Inhibition of SRC and/or Focal Adhesion Kinase (FAK) in Peripheral Blood Mononuclear Cells
Obtain blood samples to characterize plasma level of dasatinib and inhibition of SRC and/or FAK in peripheral blood mononuclear cells 2 hours after ingestion of drug at 2-4 weeks from the start of treatment if activity of the drug in a sarcoma subtype warrants further study.
Time frame: 2-4 weeks from start of treatment
Number of Participants With Tumors With Kinase Expression
Obtain tumor tissue for creation of tissue microarrays to examine the frequency of kinase expression such as SRC and/or FAK in leiomyosarcoma, liposarcoma, osteosarcoma, MFH, rhabdomyosarcoma, MPNST, chondrosarcoma, Ewing's, Alveolar soft part sarcoma (ASPS), chordoma, epithelioid sarcoma, giant cell tumor of bone, hemangiopericytoma, and GIST if activity of the drug in a subtype warrants further study. The outcome measure demonstrates the number of participants who had tissue that was able to generate tissue microarray for kinase expression.
Time frame: Up to 37 weeks
Number of Participants With Tumors With Mutations in Kinases
Obtain tumor tissue to examine the frequency of mutations in kinases such as PDGFR in leiomyosarcoma, liposarcoma, osteosarcoma, MFH, rhabdomyosarcoma, MPNST, chondrosarcoma, Ewing's, ASPS, chordoma, epithelioid sarcoma, giant cell tumor of bone, hemangiopericytoma and GIST if activity of the drug in a subtype warrants further study. The outcome measure demonstrates the tissue that was able to generate tissue microarray for PDGFR analysis.
Time frame: Up to 37 weeks
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