Imatinib + Cetuximab for Head and Neck Cancer

Overseen By Cancer Connect

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Wisconsin, Madison

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a combination of two drugs, imatinib and cetuximab, in patients with head and neck cancer who are about to undergo surgery or radiation. Researchers want to see if a specific protein in the tumor cells affects how well the treatment works. Participants will be involved in the study for over a year. Imatinib has been used for several years in the treatment of chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).

Research Team

Justine Bruce, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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.

Inclusion Criteria

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.

My oropharyngeal cancer is HPV-negative.

Exclusion Criteria

I haven't had chemotherapy or radiotherapy in the last 4 to 6 weeks.

Subjects who are receiving any other investigational agents

I do not have any severe illnesses that are not under control.

Treatment Details

Interventions

• Cetuximab (Monoclonal Antibodies)
• Imatinib (Tyrosine Kinase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Imatinib Cetuximab Combination Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+