Sarcoma
Conditions
Keywords
PDX, TumorGraft, Patient derived xenograft, sarcoma
Brief summary
Patients with recurrent or metastatic sarcoma will be consented to develop a patient derived xenograft (PDX or TumorGraft) model of their tumor to perform drug sensitivity testing. The purpose of the study is to evaluate the accuracy of the patient derived xenograft (PDX) model in predicting patient clinical response to the same drug treatment.
Interventions
OTHERPDX drug sensitivity testing
Patient derived xenograft (PDX) models will be developed for each patient and drug activity assessed in their personalized PDX model. PDX drug sensitivity information will be provided to the treating physician.
Sponsors
Mount Sinai Hospital, Canada
Champions Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 15 years of age or older * Patients with metastatic sarcoma who have had no more than one prior systemic treatment for metastatic disease * Patients with recurrent sarcoma at relapse * Patients with confirmed histological diagnosis of sarcoma or suspected diagnosis of sarcoma. Some specific subtypes of sarcoma are NOT eligible (Gastrointestinal Stromal Tumor (GIST), carcinosarcoma, sarcomatoid mesothelioma, and metastatic phyllodes tumor) * If initial suspected diagnosis of sarcoma, must have sarcoma diagnosis confirmed prior to proceeding with PDX drug sensitivity testing * Must have measureable disease for computed tomography (CT) scan or magnetic resonance imaging (MRI) evaluation following biopsy or surgery to obtain tissue for PDX development. * No plan for concurrent chemoradiation, for target lesions that will be used for drug treatment correlation with PDX * Fresh tumor tissue available for PDX development * Eastern Cooperative Oncology Group performance status of 0-1 * Life expectancy exceeds 6 months * Plan to receive systemic therapy * Informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients' whose personalized PDX model accurately predicts clinical response to therapy with same drug treatment. | 3 years | Overall accuracy as assessed by evaluating Response Evaluation Criteria In Solid Tumors (RECIST) criteria in patient tumor and correlating to tumor regression in PDX model for same drug treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients' whose personalized PDX model accurately predicts clinical response to therapy over subsequent lines of therapy. | 3 years | Overall accuracy as assessed by evaluating RECIST criteria in patient and correlating to tumor regression in PDX model for same drug treatment, over subsequent lines of therapy. |
| Factors that impact on engraftment success. | 2 years | % engraftment of tumor as a function of patient and tumor characteristics. |
| Factors that impact time to drug sensitivity testing. | 2 years | Time to PDX drug sensitivity testing as a function of patient and tumor characteristics. |
Countries
Canada
Outcome results
None listed