Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
Head and neck cancer, Patient derived Xenograft, Chemotherapy, Metastases
Brief 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.
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.
Interventions
OTHERDrug 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)
Sponsors
Champions Oncology
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the rate of PDX engraftment for HNSCC and RMHNSCC samples | 1-2 years | — |
| Time to engraftment | 1-2 years | — |
| Percentage of models successfully undergoing drug testing | 1-2 years | — |
| Participant status at the time of completion of drug testing | 1-2 years | 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). |
Countries
Canada
Outcome results
None listed