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

Head and Neck Squamous Cell Carcinoma Clinical Trial

— Xenograft  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752932
• Other study ID #: 106515
• Status: Completed
• Phase: N/A
• First received: February 24, 2016
• Last updated: October 16, 2017
• Start date: November 2015
• Est. completion date: October 12, 2017

Study information

• Verified date: March 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 12, 2017
• Est. primary completion date: October 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Neoplasms, Squamous Cell

Intervention

Other:
• 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)

Locations

Country	Name	City	State
Canada	London Regional Cancer Program	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Champions Oncology

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the rate of PDX engraftment for HNSCC and RMHNSCC samples		1-2 years
Primary	Time to engraftment		1-2 years
Primary	Percentage of models successfully undergoing drug testing		1-2 years
Primary	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).	1-2 years