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

NCT ID: NCT02720796

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-11-30

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.

Detailed Description

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Conditions

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Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

PDX drug sensitivity testing

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mount Sinai Hospital, Canada

OTHER

Sponsor Role collaborator

Champions Oncology

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Albiruni Razak, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital, Toronto, Ontario, Canada

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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CO-001

Identifier Type: -

Identifier Source: org_study_id