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

• Sponsor: Lawson Health Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02752932
• Collaborator: Champions Oncology (Industry)
• Enrollment: 41
• Location: 1
• Arms: 2
• Duration (Months): 23.4
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Squamous Cell Carcinoma	Other: Drug testing on PDX per Investigator's choice (upto 4)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: TumorGraft- Guided Therapy for Improved Outcomes in Head and Neck Squamous Cell Cancer- A Feasibility Study
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Oct 12, 2017
• Actual Study Completion Date: Oct 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	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)
Other: 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.	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)

Outcome Measures

Primary Outcome Measures

1. To determine the rate of PDX engraftment for HNSCC and RMHNSCC samples [1-2 years]

2. Time to engraftment [1-2 years]

3. Percentage of models successfully undergoing drug testing [1-2 years]

4. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London Regional Cancer Program	London	Ontario	Canada	N6A 4L6

Sponsors and Collaborators

• Lawson Health Research Institute
• Champions Oncology

Investigators

• Principal Investigator: Anthony Nichols, MD, FRCSC, London Regional Cancer Program
• Principal Investigator: Eric Winquist, MD, FRCPC, London Regional Cancer Program

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT02752932
• Other Study ID Numbers: 106515
• First Posted: Apr 27, 2016
• Last Update Posted: Oct 18, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Lawson Health Research Institute: Head and neck cancer; Patient derived Xenograft; Chemotherapy; Metastases
• Additional relevant MeSH terms: Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Neoplasms, Squamous Cell

Study Results

No Results Posted as of Oct 18, 2017