NCT02720796

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 28, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

2.1 years

First QC Date

November 5, 2015

Last Update Submit

October 5, 2017

Conditions

Sarcoma

Keywords

PDXTumorGraftPatient derived xenograftsarcoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of patients' whose personalized PDX model accurately predicts clinical response to therapy over subsequent lines of therapy.

    3 years

  • Factors that impact on engraftment success.

    2 years

  • Factors that impact time to drug sensitivity testing.

    2 years

Study Arms (1)

PDX drug sensitivity testing

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.

Other: PDX drug sensitivity testing

Interventions

PDX drug sensitivity testingOTHER

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.

PDX drug sensitivity testing

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Albiruni Razak, MD

    Mount Sinai Hospital, Toronto, Ontario, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2015

First Posted

March 28, 2016

Study Start

November 1, 2015

Primary Completion

November 30, 2017

Study Completion

November 30, 2017

Last Updated

October 6, 2017

Record last verified: 2017-10

Locations

CA(1)