ACTIVE_NOT_RECRUITING

Pilot Study of Imatinib Cetuximab Combo for H & N Cancer

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Conditions

Head and Neck CancerSquamous Cell Carcinoma of Head and Neck

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to find if levels of a protein called AXL in tumor cells relate to how tumors respond to cetuximab (CTX) combined with imatinib in participants with head and neck cancer. This interventional study will occur in the time between diagnosis of your cancer and surgery to remove your tumor or radiation or chemoradiation treatment of your primary cancer. Participants will undergo a research blood draw and a research biopsy as part of the screening process, and will be in this research study for approximately 13 to 16 months.

Official Title

A Pilot Window of Opportunity Study of Imatinib in Combination With Cetuximab in Patients With Squamous Cell Carcinomas of the Head and Neck

Quick Facts

Study Start:2023-04-18
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05816785

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18 years at the time of consent.
  2. * Histological confirmation of squamous cell carcinoma of the head and neck.
  3. * For those patients with oropharyngeal cancer, subjects must have either
  4. * HPV-negative status by p16 expression or HPV-DNA Expression.
  5. * HPV-positive status by p16 expression AND a \>10 pack year smoking history.
  6. * Subjects must be appropriate candidates for definitive curative intent treatment, either via surgical resection, definitive radiation therapy alone, or definitive concurrent chemoradiation therapy.
  7. * For the screening research biopsy, subjects must have sufficient tumor volume (approximately 10 cc) to accommodate at minimum 2-3 core samples for the research biopsy.
  8. * For the post-treatment (CTX/Imatinib) research biopsy, subjects who are scheduled to receive definitive radiation therapy (+/- concurrent chemotherapy) are required to have sufficient tumor volume to accommodate at minimum 2-3 core samples for the research biopsy.
  9. * Demonstrate adequate organ function; all screening labs to be obtained within 28 days prior to registration.
  1. * Subjects with a diagnosis of nasopharyngeal carcinoma, advanced cutaneous squamous cell carcinoma of the head and neck, or salivary gland tumors are excluded from this study.
  2. * Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol.
  3. * Prior chemotherapy, radiotherapy, or major surgery within 8 weeks of study enrollment or those who have not recovered (to grade ≤ 1 or baseline) from clinically significant adverse events due to agents administered more than 8 weeks earlier (alopecia and fatigue excluded). Clinical significance to be determined by the study investigator.
  4. * Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
  5. * Subjects who are receiving any other investigational agents.
  6. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to imatinib or CTX.

Contacts and Locations

Principal Investigator

Justine Bruce, MD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Justine Bruce, MD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-18
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2023-04-18
Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Head and Neck Cancer
  • Squamous Cell Carcinoma of Head and Neck