NCT02752932

Brief Summary

Primary objectives:

  1. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2017

Completed
Last Updated

October 18, 2017

Status Verified

March 1, 2017

Enrollment Period

1.9 years

First QC Date

February 24, 2016

Last Update Submit

October 16, 2017

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and neck cancerPatient derived XenograftChemotherapyMetastases

Outcome Measures

Primary Outcomes (4)

  • 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

    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

Study Arms (2)

HNSCC -PDX development

OTHER

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)

RMHNSCC -PDX drug testing

OTHER

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)

Interventions

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

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

HNSCC -PDX developmentRMHNSCC -PDX drug testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with recurrent metastatic squamous cell carcinoma of the head and neck.
  • Lesion amenable to biopsy (1 cm or more)
  • Lesion capable of yielding 4 biopsy cores
  • years or older
  • Capable of providing and signing for informed consent

You may not qualify if:

  • Cognitive impairment prohibitive to providing informed consent
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckHead and Neck NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anthony Nichols, MD, FRCSC

    London Regional Cancer Program

    PRINCIPAL INVESTIGATOR

  • Eric Winquist, MD, FRCPC

    London Regional Cancer Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2016

First Posted

April 27, 2016

Study Start

November 1, 2015

Primary Completion

October 12, 2017

Study Completion

October 12, 2017

Last Updated

October 18, 2017

Record last verified: 2017-03

Locations

CA(1)