Study on Cetuximab and Interleukin-12 for Treating Head and Neck Cancer That Has Returned, Spread, or Cannot Be Surgically Removed
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT01468896
This clinical trial is testing a combination of two treatments, cetuximab and interleukin-12, to see if they can help treat squamous cell carcinoma of the head and neck that has come back, spread, or cannot be removed by surgery. The study aims to find the best dose and evaluate how well these treatments work together.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is exploring the use of two treatments, cetuximab and recombinant interleukin-12, for patients with squamous cell carcinoma of the head and neck that has returned, spread to other parts of the body, or cannot be removed by surgery. Cetuximab is a type of immunotherapy that may help the immune system attack cancer cells, while interleukin-12 may stimulate white blood cells to kill tumor cells. The study aims to find the best dose of interleukin-12 and to see how well the combination of these treatments works in shrinking tumors.
Description
The study is divided into two phases. In Phase I, researchers will determine a safe and tolerable dose of interleukin-12 to use with cetuximab. In Phase II, they will evaluate how well this combination works in treating the cancer.
Patients will receive cetuximab through an IV on the first day and interleukin-12 as an injection under the skin on the second and fifth days, starting from the second course of treatment. This treatment cycle repeats every two weeks for up to 12 cycles, as long as the cancer does not progress and side effects are manageable. If patients respond well or their disease remains stable, they may continue treatment until the cancer progresses.
After completing the study treatment, patients will be monitored for one year to assess their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of squamous cell carcinoma of the head and neck that has returned, spread, or cannot be surgically removed.
- May have received any number of previous treatments for metastatic or recurrent cancer.
- Do not need to have had prior cetuximab treatment to join the study.
- Be in relatively good health with a performance status score of 0 to 2.
- Have a life expectancy of more than 6 months.
- Meet specific blood count and organ function requirements.
- Women of childbearing potential and men must agree to use effective contraception during the study.
- Be able to understand and sign a written informed consent document.
Exclusion Criteria
- Have received chemotherapy or radiotherapy within the last 4 weeks (or 6 weeks for certain drugs) before starting the study.
- Be participating in another clinical trial with investigational drugs.
- Have untreated or unstable brain metastases.
- Have a history of severe allergic reactions to similar treatments.
- Have uncontrolled illnesses such as infections, heart failure, or psychiatric conditions that could interfere with the study.
- Be pregnant or breastfeeding, due to potential risks to the baby.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| MedStar Georgetown University Hospital | 20007 | Washington D.C. | District of Columbia |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.