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

Not Applicable

Terminated

• Conditions: Sarcoma
• Interventions: Other: PDX drug sensitivity testing

• Registration Number: NCT02720796
• Lead Sponsor: Champions Oncology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-28
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-06
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PDX drug sensitivity testing	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada