A Prospective Correlative Trial of Personalized Patient-Derived Xenograft (PDX or TumorGraft) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Champions Oncology
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Number of patients' whose personalized PDX model accurately predicts clinical response to therapy with same drug treatment.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
PDX 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.
Intervention: PDX drug sensitivity testing (Other)
Outcomes
Primary Outcomes
Number of patients' whose personalized PDX model accurately predicts clinical response to therapy with same drug treatment.
Time Frame: 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 Outcomes
- Number of patients' whose personalized PDX model accurately predicts clinical response to therapy over subsequent lines of therapy.(3 years)
- Factors that impact on engraftment success.(2 years)
- Factors that impact time to drug sensitivity testing.(2 years)