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

October 5, 2017 updated by: Champions Oncology

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

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.
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.
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.
Time Frame: 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.
3 years
Factors that impact on engraftment success.
Time Frame: 2 years
% engraftment of tumor as a function of patient and tumor characteristics.
2 years
Factors that impact time to drug sensitivity testing.
Time Frame: 2 years
Time to PDX drug sensitivity testing as a function of patient and tumor characteristics.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Champions Oncology

Collaborators

Mount Sinai Hospital, Canada

Investigators

  • Principal Investigator: Albiruni Razak, MD, Mount Sinai Hospital, Toronto, Ontario, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ANTICIPATED)

November 30, 2017

Study Completion (ANTICIPATED)

November 30, 2017

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

March 22, 2016

First Posted (ESTIMATE)

March 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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