Head and Neck Squamous Cell Carcinoma (HNSCC) Clinical Trials

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Therapeutic Drug Screening Using a Novel Implantable Microdevice (IMD) in Head and Neck Cancers: a Window of Opportunity Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

This research study is studying the effect of different drugs as possible treatments for salivary and other head and neck cancers/ The name of the study intervention involved in this study is: \-- implantable microdevice

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants must have histologically confirmed head and neck cancer (salivary or ACC type, or squamous cell carcinoma) without evidence of recurrent, metastatic or advanced, incurable disease undergoing definitive surgical management; any stage disease is permitted (American Joint Committee on Cancer 2017 8th edition).

• Age 18 years or older.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

• A measurable primary tumor site both clinically and radiologically measuring at least 1 x 1 cm.

• \- Patients must be deemed medically fit to undergo both percutaneous and surgical procedures by their treating head and neck surgeon and medical oncologist.

• Participants will undergo laboratory testing within 7 days prior to the microdevice placement: they are required to have a platelet count ≥50,000/mcL, PT/INR \<2, and aPTT \<1.5x upper limit of normal.

• Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days

• Ability to understand and the willingness to sign a written informed consent document.

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Glenn J. Hanna, M.D.
glenn_hanna@dfci.harvard.edu
(617) 632-3090
Backup
Oliver Jonas, Ph.D.
OJONAS@BWH.HARVARD.EDU
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2029-08-01
Participants
Target number of participants: 30
Treatments
Experimental: IMD PLACEMENT + SURGICAL RESECTION + ADJUVANT TREATMENT ARM
Newly diagnosed, localized head and neck cancers undergoing surgical resection~* Interventional radiology guided IMD placement~* Planned oncologic resection with IMD retrieval 3-5 days after placement~* Standard of care adjuvant treatment~* Tumor specimen analysis for local drug response and molecular analysis
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: Adenoid Cystic Carcinoma Research Foundation

This content was sourced from clinicaltrials.gov

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