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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02720796
• Other study ID #: CO-001
• Status: Terminated
• Phase: N/A
• First received: November 5, 2015
• Last updated: October 5, 2017
• Start date: November 2015
• Est. completion date: November 30, 2017

Study information

• Verified date: October 2017
• Source: Champions Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Sarcoma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Champions Oncology	Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Factors that impact on engraftment success.	% engraftment of tumor as a function of patient and tumor characteristics.	2 years
Secondary	Factors that impact time to drug sensitivity testing.	Time to PDX drug sensitivity testing as a function of patient and tumor characteristics.	2 years