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TumorGraft- Guided Therapy for Improved Outcomes in Head and Neck Squamous Cell Cancer- A Feasibility Study (Xenograft)

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Drug testing on PDX per Investigator's choice (upto 4)
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Squamous Cell Carcinoma focused on measuring Head and neck cancer, Patient derived Xenograft, Chemotherapy, Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with recurrent metastatic squamous cell carcinoma of the head and neck.
  2. Lesion amenable to biopsy (1 cm or more)
  3. Lesion capable of yielding 4 biopsy cores
  4. 18 years or older
  5. Capable of providing and signing for informed consent

Exclusion Criteria:

  1. Cognitive impairment prohibitive to providing informed consent
  2. Pregnant or lactating women.

Sites / Locations

  • London Regional Cancer Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

HNSCC -PDX development

RMHNSCC -PDX drug testing

Arm Description

Participants with HNSCC who will undergo curative surgery will be included in this group. This involves PDX development only, no drug testing will be done on the PDX.

Participants with RMHNSCC who are under palliative treatment will be included in this group. Drug testing on PDX per Investigator's choice (upto 4): PDX will be developed and upto four Chemotherapeutics (that are funded in Ontario) will be tested on the PDX. Chemotherapeutics will be selected at the discretion of the treating Medical Oncologists. Result of the drug testing will be provided to the responsible physician and can be utilized in patient care.

Outcomes

Primary Outcome Measures

To determine the rate of PDX engraftment for HNSCC and RMHNSCC samples
Time to engraftment
Percentage of models successfully undergoing drug testing
Participant status at the time of completion of drug testing
Participant status at the time of completion of drug testings(i.e. what percentage of participants are alive and well enough to receive further chemo).

Secondary Outcome Measures

Full Information

First Posted
February 24, 2016
Last Updated
October 16, 2017
Sponsor
Lawson Health Research Institute
Collaborators
Champions Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT02752932
Brief Title
TumorGraft- Guided Therapy for Improved Outcomes in Head and Neck Squamous Cell Cancer- A Feasibility Study
Acronym
Xenograft
Official Title
TumorGraft- Guided Therapy for Improved Outcomes in Head and Neck Squamous Cell Cancer- A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
October 12, 2017 (Actual)
Study Completion Date
October 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Champions Oncology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary objectives: Evaluate the feasibility of rapidly accruing 30 participants with recurrent metastatic head and neck squamous cell carcinoma for the development of patient derived xenographs (PDX) from fresh, real time biopsies in which sensitivity to < 4 Ontario funded chemotherapeutic regimen will be tested. Written feedback to the primary oncologist will be provided. There is also a curative intent cohort of 30 participants undergoing surgical resection with curative intent. These PDX models will undergo exome sequencing with written feedback. Feasibility in both surgical and recurrent cohorts will be a measure of i) engraftment rate, ii) patient status at the time of drug testing completion and iii) rate of accrual.
Detailed Description
Tumour samples from 30 participants with HNSCC that undergone curative surgery will be used to establish patient-derived xenografts (PDXs). These tumours will also undergo exome sequencing. This will provide a biobank of PDX models with available genomic information for future research projects. Another 30 participants with recurrent or metastatic HNSCC (RMHNSCC) will be recruited to this study. PDX models will be developed from these patient tumours, followed by genomic sequencing. PDX models are developed by transplanting small tumour pieces into immunocompromised mice. These mice are then treated with different available drugs for RMHNSCC at the discretion of their medical oncologist. These mice will be then followed up to examine the tumour response to treatments. When studied in clinic, PDX models have shown high correlation with patient response to the treatment. The PDX drug testing results will be provided to the treating medical oncologist to guide care at the oncologists discretion. Investigators' hope is that improved chemotherapy responses are observed with this strategy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
Keywords
Head and neck cancer, Patient derived Xenograft, Chemotherapy, Metastases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HNSCC -PDX development
Arm Type
Other
Arm Description
Participants with HNSCC who will undergo curative surgery will be included in this group. This involves PDX development only, no drug testing will be done on the PDX.
Arm Title
RMHNSCC -PDX drug testing
Arm Type
Other
Arm Description
Participants with RMHNSCC who are under palliative treatment will be included in this group. Drug testing on PDX per Investigator's choice (upto 4): PDX will be developed and upto four Chemotherapeutics (that are funded in Ontario) will be tested on the PDX. Chemotherapeutics will be selected at the discretion of the treating Medical Oncologists. Result of the drug testing will be provided to the responsible physician and can be utilized in patient care.
Intervention Type
Other
Intervention Name(s)
Drug testing on PDX per Investigator's choice (upto 4)
Intervention Description
Drug of Investigator's choice (upto 4 Ontario funded Chemotherapeutics) will be tested on PDX (Patient Derived Xenografts)
Primary Outcome Measure Information:
Title
To determine the rate of PDX engraftment for HNSCC and RMHNSCC samples
Time Frame
1-2 years
Title
Time to engraftment
Time Frame
1-2 years
Title
Percentage of models successfully undergoing drug testing
Time Frame
1-2 years
Title
Participant status at the time of completion of drug testing
Description
Participant status at the time of completion of drug testings(i.e. what percentage of participants are alive and well enough to receive further chemo).
Time Frame
1-2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with recurrent metastatic squamous cell carcinoma of the head and neck. Lesion amenable to biopsy (1 cm or more) Lesion capable of yielding 4 biopsy cores 18 years or older Capable of providing and signing for informed consent Exclusion Criteria: Cognitive impairment prohibitive to providing informed consent Pregnant or lactating women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Nichols, MD, FRCSC
Organizational Affiliation
London Regional Cancer Program
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Winquist, MD, FRCPC
Organizational Affiliation
London Regional Cancer Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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TumorGraft- Guided Therapy for Improved Outcomes in Head and Neck Squamous Cell Cancer- A Feasibility Study

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