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Monoclonal Antibodies
Imatinib + Cetuximab for Head and Neck Cancer
Phase < 1
Recruiting
Led By Justine Bruce, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
Study Summary
This trial tests whether a protein in cancer cells can predict how head and neck tumors respond to a combination of two treatments. Participants will be monitored for 13-16 months to assess the effectiveness.
Who is the study for?
Adults over 18 with squamous cell carcinoma of the head and neck, who are candidates for curative surgery or chemoradiation. They must have a tumor large enough for biopsy samples and adequate organ function. Excluded are those with certain other cancers, recent major treatments, ongoing investigational drug use, allergies to study drugs, or severe medical conditions.Check my eligibility
What is being tested?
This trial tests if protein AXL levels in tumors predict response to cetuximab combined with imatinib in head and neck cancer patients. Participants will be studied from diagnosis until up to 16 months after treatment involving surgery or chemoradiation.See study design
What are the potential side effects?
Possible side effects include allergic reactions related to either imatinib or cetuximab (such as skin rashes), as well as general risks associated with biopsies like bleeding and infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Ki67 from pre- versus post-imatinib/cetuximab treated tumors
Secondary outcome measures
Adverse Events that are probably related to CTX and imatinib prior to the start of definitive concurrent chemoradiation therapy or surgical resection
Objective response rate (ORR)
Rate of hospital re-admissions
Trial Design
1Treatment groups
Experimental Treatment
Group I: Imatinib Cetuximab CombinationExperimental Treatment2 Interventions
Participants will receive two doses of CTX and a minimum of an 8 day (maximum 14 day) course of imatinib prior to definitive surgery or definitive radiation/chemoradiation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imatinib
2011
Completed Phase 3
~3940
Cetuximab
2011
Completed Phase 3
~2480
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,531 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,990 Total Patients Enrolled
Justine Bruce, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
5 Previous Clinical Trials
48 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy or radiotherapy in the last 4 to 6 weeks.I am a candidate for treatment aimed at curing my cancer through surgery, radiation, or both.My tumor is large enough for multiple biopsy samples after treatment.I do not have any severe illnesses that are not under control.My oropharyngeal cancer is HPV-negative.My tumor is large enough for multiple biopsy samples.I am HPV-positive and have a history of smoking more than 10 pack-years.I haven't had chemotherapy, radiotherapy, or major surgery in the last 8 weeks and have recovered from any significant side effects.My organ functions are within normal ranges as per recent tests.I do not have nasopharyngeal carcinoma, advanced cutaneous squamous cell carcinoma of the head and neck, or salivary gland tumors.My cancer is a type of squamous cell carcinoma in the head or neck.I am older than 18 years.
Research Study Groups:
This trial has the following groups:- Group 1: Imatinib Cetuximab Combination
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for participants in this medical experiment?
"This trial, which was initially posted on April 1st 2023, is no longer recruiting patients. The data hosted by clinicaltrials.gov has been modified as recently as 4/4/2023 and records that there are now over two thousand nine-hundred thirty six other medical studies actively looking for participants."
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