Combination treatment of imatinib and cetuximab for head and neck cancer
A Pilot Window of Opportunity Study of Imatinib in Combination With Cetuximab in Patients With Squamous Cell Carcinomas of the Head and Neck
This study is testing if a combination of two cancer drugs, imatinib and cetuximab, can help people with head and neck cancer respond better to treatment.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Drugs / interventions | Imatinib, chemotherapy, radiation, cetuximab |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT05816785 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of a combination therapy using imatinib and cetuximab in patients diagnosed with head and neck squamous cell carcinoma. Participants will undergo a blood draw and biopsy to assess the relationship between AXL protein levels in tumor cells and treatment response. The study will take place during the period between cancer diagnosis and definitive treatment, such as surgery or radiation. The primary goal is to determine the proportion of patients responding to the treatment based on pre- and post-treatment samples collected over approximately 13 to 16 months.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically confirmed squamous cell carcinoma of the head and neck who are suitable for definitive curative treatment.
Not a fit: Patients with non-squamous cell carcinoma or those not eligible for definitive treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with head and neck cancer.
How similar studies have performed: While this approach is novel, similar studies have shown promise in targeting specific proteins to enhance treatment responses in cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years at the time of consent. * Histological confirmation of squamous cell carcinoma of the head and neck. * For those patients with oropharyngeal cancer, subjects must have either * HPV-negative status by p16 expression or HPV-DNA Expression. * HPV-positive status by p16 expression AND a \>10 pack year smoking history. * Subjects must be appropriate candidates for definitive curative intent treatment, either via surgical resection, definitive radiation therapy alone, or definitive concurrent chemoradiation therapy. * 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. * 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. * Demonstrate adequate organ function; all screening labs to be obtained within 28 days prior to registration. Exclusion Criteria: * 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. * 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. * 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. * Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. * Subjects who are receiving any other investigational agents. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to imatinib or CTX.
Where this trial is running
Madison, Wisconsin
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Justine Bruce, MD — University of Wisconsin, Madison
- Study coordinator: Cancer Connect
- Email: cancerconnect@uwcarbone.wisc.edu
- Phone: 800-622-8922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.