Back to resultsPatient-Derived Xenograft (PDX) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma
Primary Purpose
Sarcoma
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PDX drug sensitivity testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Sarcoma focused on measuring PDX, TumorGraft, Patient derived xenograft, sarcoma
Eligibility 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
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PDX drug sensitivity testing
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Factors that impact on engraftment success.
% engraftment of tumor as a function of patient and tumor characteristics.
Factors that impact time to drug sensitivity testing.
Time to PDX drug sensitivity testing as a function of patient and tumor characteristics.
Full Information
NCT ID
NCT02720796
First Posted
November 5, 2015
Last Updated
October 5, 2017
Sponsor
Champions Oncology
Collaborators
Mount Sinai Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT02720796
Brief Title
Patient-Derived Xenograft (PDX) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma
Official Title
A Prospective Correlative Trial of Personalized Patient-Derived Xenograft (PDX or TumorGraft) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruitment barriers
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 30, 2017 (Anticipated)
Study Completion Date
November 30, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Champions Oncology
Collaborators
Mount Sinai Hospital, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
PDX, TumorGraft, Patient derived xenograft, sarcoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PDX drug sensitivity testing
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
PDX drug sensitivity testing
Intervention Description
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 Measure Information:
Title
Number of patients' whose personalized PDX model accurately predicts clinical response to therapy with same drug treatment.
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of patients' whose personalized PDX model accurately predicts clinical response to therapy over subsequent lines of therapy.
Description
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.
Time Frame
3 years
Title
Factors that impact on engraftment success.
Description
% engraftment of tumor as a function of patient and tumor characteristics.
Time Frame
2 years
Title
Factors that impact time to drug sensitivity testing.
Description
Time to PDX drug sensitivity testing as a function of patient and tumor characteristics.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albiruni Razak, MD
Organizational Affiliation
Mount Sinai Hospital, Toronto, Ontario, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Patient-Derived Xenograft (PDX) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma
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