NCT04188951CompletedEarly phase 1
HFHS-1801-A Pilot Study of Immunotherapy As Consolidation Therapy for Patients with Recurrent Head and Neck Cancer
HFHS-1801-A Pilot Study of Immunotherapy As Consolidation Therapy for Patients with Recurrent Head and Neck Cancer High Risk Pathologic Features Following Surgical Salvage and Are Not Eligible for Post-operative Radiation Therapy
Source: ClinicalTrials.gov · Last updated 4 Dec 2024
Brief summary (registry, in English)
The study is a pilot study to explore the feasibility and efficacy of immunotherapy following salvage surgery for recurrent head and neck cancer.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 31 Oct 2019
- Start date
- 4 Oct 2019
- Primary completion date
- 15 Jun 2023
- Lead sponsor
- Henry Ford Health System
- Diseases
- Head and neck cancer
- NCT number
- NCT04188951
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 10
- From 4 Oct 2019 to the primary completion date, 15 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient is eligible for radiation therapy.
- Patients previously treated with immunotherapy \<12months prior
Other illness
- Patients with macroscopic residual disease
- Contraindications for immunotherapy, autoimmune disease, allergy to medication, steroid use at baseline.
- Patients with other previous cancers excluding CIN, DCIS, non-melanoma skin cancers
- Patients with synchronous cancers "not included in the inclusion criteria"
Other
- Performance status more than 2.
Who the study is looking for
- Patients must be 18 years or older, of either gender, with the ability to consent to participation in the study.
- Patients must have a history of squamous cell carcinoma of the head and neck involving any sub-site in the head and neck area except nasopharynx, paranasal sinuses, and salivary gland tumors.
- All patients must have recurred following definitive therapy with any combination of surgery, radiation, and/or chemotherapy.
- All patients must have undergone salvage surgery in an attempt to excise all recurrent disease.
- Salvage radiation therapy must not be an option available to the patient.
- Patients must have high risk features such extra nodal invasion, positive margins, perineural invasion or vascular embolism.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.