Clinical trial NCT02752932: TumorGraft- Guided Therapy for Improved Outcomes in Head and Neck Squamous Cell Cancer- A Feasibility Study
Official title: TumorGraft- Guided Therapy for Improved Outcomes in Head and Neck Squamous Cell Cancer- A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Head and neck cancer
Patient derived Xenograft
Chemotherapy
Metastases
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Champions Oncology
First posted: 2016-04-27
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine the rate of PDX engraftment for HNSCC and RMHNSCC samples
timeFrame: 1-2 years
measure: Time to engraftment
timeFrame: 1-2 years
measure: Percentage of models successfully undergoing drug testing
timeFrame: 1-2 years
measure: Participant status at the time of completion of drug testing
timeFrame: 1-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
Study officials:
affiliation: London Regional Cancer Program
name: Anthony Nichols, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: London Regional Cancer Program
name: Eric Winquist, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: