Study on Combining Pembrolizumab and Cesium 131 Radiation with Surgery for Recurrent Head and Neck Cancer
Sponsor: University of Cincinnati
ClinicalTrials ID:NCT04340258
This clinical trial is testing a new treatment approach that combines the drug pembrolizumab and a type of radiation therapy called Cesium 131 brachytherapy with surgery for patients with head and neck cancer that has come back.
Patient Parameters
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Program Overview
The purpose of this study is to see if using pembrolizumab, a drug that helps the immune system fight cancer, along with Cesium 131 radiation seeds during surgery, can improve outcomes for patients with head and neck cancer that has returned and can be surgically removed. Patients will receive pembrolizumab before and after surgery, and the study will monitor their health and cancer status over time.
Description
This study involves patients with head and neck cancer that has come back and can be removed with surgery. Participants will first receive a dose of pembrolizumab, a medication that boosts the immune system to fight cancer, before undergoing surgery to remove the cancer. During the surgery, small radioactive seeds called Cesium 131 will be implanted to target any remaining cancer cells.
After surgery, participants will continue to receive pembrolizumab every three weeks for six months. The study will first enroll a small group of three patients to ensure the treatment is safe. If no serious side effects are observed, more patients will be enrolled to further evaluate the treatment's effectiveness in preventing cancer from returning over two years.
Throughout the study, researchers will collect tissue and blood samples to study the immune response and monitor the patients' health. Participants will have regular follow-up visits every three weeks during the first six months of treatment, then monthly for three months, and every three months for two years to track their progress and overall survival.
Eligibility Criteria
Inclusion Criteria
- Have head and neck cancer that has returned and can be surgically removed.
- If previously treated with radiation, must have recovered from any immediate side effects to a mild level.
- The tumor must be considered removable by surgery.
Exclusion Criteria
- Have an exposed carotid artery that requires surgical intervention.
- Have active complications involving the throat and skin.
- Have more than one site of cancer spread to distant parts of the body.
- Have received immune-based cancer treatment in the last six months.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Cincinnati Medical Center | 45219 | Cincinnati | Ohio |
| Thomas Jefferson | 19144 | Philadelphia | Pennsylvania |
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