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

NCT ID: NCT02752932

Last Updated: 2017-10-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-10-12

Brief Summary

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Primary objectives:

1. 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.
2. 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.
3. 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

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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.

Conditions

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Head and Neck Squamous Cell Carcinoma

Keywords

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Head and neck cancer Patient derived Xenograft Chemotherapy Metastases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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HNSCC -PDX development

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.

Group Type OTHER

Drug testing on PDX per Investigator's choice (upto 4)

Intervention Type OTHER

Drug of Investigator's choice (upto 4 Ontario funded Chemotherapeutics) will be tested on PDX (Patient Derived Xenografts)

RMHNSCC -PDX drug testing

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.

Group Type OTHER

Drug testing on PDX per Investigator's choice (upto 4)

Intervention Type OTHER

Drug of Investigator's choice (upto 4 Ontario funded Chemotherapeutics) will be tested on PDX (Patient Derived Xenografts)

Interventions

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Drug testing on PDX per Investigator's choice (upto 4)

Drug of Investigator's choice (upto 4 Ontario funded Chemotherapeutics) will be tested on PDX (Patient Derived Xenografts)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Champions Oncology

INDUSTRY

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony Nichols, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

London Regional Cancer Program

Eric Winquist, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

London Regional Cancer Program

Locations

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London Regional Cancer Program

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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106515

Identifier Type: -

Identifier Source: org_study_id