Using a radioactive drug to find cancer spread in head and neck patients
Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer
This study is testing a new radioactive drug to see if it can help doctors find cancer spread in the lymph nodes of patients with head and neck cancer before surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Drugs / interventions | panitumumab |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05901545 on ClinicalTrials.gov |
What this trial studies
This phase I trial evaluates the safety and effectiveness of indium In 111 panitumumab for identifying sentinel lymph nodes in patients with head and neck squamous cell carcinoma (HNSCC) prior to surgery. The study involves administering a loading dose of panitumumab followed by a radioactive agent, 111In-panitumumab, to enhance imaging of lymph nodes. The primary objective is to assess safety, while secondary objectives include comparing the sensitivity and specificity of this method against conventional imaging techniques. The trial aims to improve preoperative detection of lymph node metastases, which is crucial for patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with biopsy-confirmed head and neck squamous cell carcinoma who are scheduled for surgical resection.
Not a fit: Patients with recent myocardial infarction, uncontrolled heart failure, significant liver disease, or a history of infusion reactions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate preoperative identification of cancer spread, potentially improving surgical outcomes and survival rates.
How similar studies have performed: Other studies have shown promise with similar imaging approaches, but this specific use of 111In-panitumumab is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 19 years. * Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck, clinically-staged as node-negative (cN0) or as clinically-suspicious node(s). * Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed. * Planned standard of care elective neck dissection for node-negative or node-positive disease. * Have acceptable hematologic status, kidney function, and liver function including the following clinical results: * Hemoglobin ≥ 9 gm/dL * White blood cell count \> 3000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Serum creatinine ≤ 1.5 times upper reference range Exclusion Criteria: * Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment. * History of infusion reactions to monoclonal antibody therapies * History of allergies to iodine * Pregnant or breastfeeding. * Magnesium or potassium lower than the normal institutional values. * Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. * Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis. * Severe renal disease or anuria.
Where this trial is running
Nashville, Tennessee
- Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Eben Rosenthal, MD — Vanderbilt University/Ingram Cancer Center
- Study coordinator: Nicole Jones
- Email: nicole.l.jones@vumc.org
- Phone: 615-936-2807
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.