Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-30 @ 10:36 AM
Study NCT ID:
NCT04188951
Status:
COMPLETED
Last Update Posted:
2024-12-04
First Post:
2019-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HFHS-1801-A Pilot Study of Immunotherapy As Consolidation Therapy for Patients with Recurrent Head and Neck Cancer
Sponsor:
Henry Ford Health System
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a pilot study to explore the feasibility and efficacy of immunotherapy following salvage surgery for recurrent head and neck cancer.
Detailed Description:
Approximately 30-40% of patients treated with a curative intent for locally advanced squamous cell carcinoma of the head and neck cancer will experience an isolated loco-regional recurrence or a second primary tumor in the previously radiated tissues1-5. Patients with recurrent head and neck cancer frequently recur locally and are still amenable for curative interventions. The current recommendations for treatment of these recurrent and second primary tumors includes surgical resection whenever possible as this has been shown to have a significantly better outcome as compared to patients treated non-surgically with radiation therapy with or without concurrent chemotherapy.
Immunotherapy is expected to be more effective with smaller amounts of disease and application of therapy when disease burden is minimal is expected to yield improved outcomes. Many trials underway at the present time explore the use of immunotherapy in earlier stages of head and neck cancer than the ones already studied. However, patients undergoing salvage therapy are understudied and no major cooperative group or industry trial is addressing this group of patients.
Immunotherapy is expected to be more effective with smaller amounts of disease and application of therapy when disease burden is minimal is expected to yield improved outcomes. Many trials underway at the present time explore the use of immunotherapy in earlier stages of head and neck cancer than the ones already studied. However, patients undergoing salvage therapy are understudied and no major cooperative group or industry trial is addressing this group of patients.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: