Patient-Derived Xenograft (PDX) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Correlative Trial of Personalized Patient-Derived Xenograft (PDX or TumorGraft) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma

Conditions
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Sarcoma

Intervention / Treatment
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* Other: PDX drug sensitivity testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PDX drug sensitivity testing<br>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. | Other: PDX drug sensitivity testing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients' whose personalized PDX model accurately predicts clinical response to therapy with same drug treatment. | 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. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients' whose personalized PDX model accurately predicts clinical response to therapy over subsequent lines of therapy. | 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. | 3 years | 
| Factors that impact on engraftment success. | % engraftment of tumor as a function of patient and tumor characteristics. | 2 years | 
| Factors that impact time to drug sensitivity testing. | Time to PDX drug sensitivity testing as a function of patient and tumor characteristics. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PDX, TumorGraft, Patient derived xenograft, sarcoma