Print

Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Participants who are receiving any other investigational agents. - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery. - Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the device placement and the potential risk to the pregnancy of the surgery/device placement. - Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures. If the patient is on systemic anticoagulation, this should be discussed with the overall PI and treating surgeon

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Combination Product: Implantable Microdevice (IMD)
    - Percutaneous CT image-guided placement of the microdevice(s). At least one, and up to 3, devices will be placed in each tumor. - Drugs will be released from the microdevice into local tumor tissues. The duration of drug release will be for a period of 3-5 days while the microdevice is in the tumor prior to retrieval. The local tissue is retrieved along with the microdevice and no residual drug will remain. - Each microdevice harbors up to 20 drugs and/or drug combinations relevant to the treatment of head and neck cancer. The drugs used will include some standard agents approved by the Food and Drug Administration (FDA) for treatment of different types of cancers, or drugs classes under investigational. - Drugs may include all or a subset of the following which each may be tested as single agents or in any number of combinations including, but not limited to: Lenvatinib, Axitinib, All trans retinoic acid (ATRA), Venetoclax, Pembrolizumab, Cisplatin, Carboplatin, Vinorelbine

Recruiting Locations

Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
Contact:
Glenn J Hanna, MD
617-632-3090
glenn_hanna@dfci.harvard.edu

Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
Contact:
Glenn Hanna, MD
617-632-3090
gjhanna@partners.org

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Glenn J. Hanna, M.D.
(617) 632-3090
glenn_hanna@dfci.harvard.edu

Detailed Description

This window-of-opportunity pilot study will assess the safety and feasibility of using an implantable microdevice (IMD) to efficiently measure local intratumor response to multiple drugs within previously untreated head and neck cancer patients undergoing definitive oncologic resection. - This research study is a Pilot Study, which is the first-time investigators are examining this study device in salivary and head and neck cancers. The placement and removal of the microdevice is being tested for the first time in this type of cancer. - This research study involves drugs that are released by a small implantable microdevice (IMD) as small as the tip of a needle, that is inserted into the tumor and is then removed 3-5 days later during surgery. - The microdevice can hold up to 20 drugs alone or in combinations in very small concentrations that are able to access the cancer through small pores in the device. When the device is removed along with the cancer at the time of surgery, it will be evaluated to understand which drug(s) may be effective to treat these cancers. It is expected that about 30 people will take part in this research study. The U.S. Food and Drug Administration (FDA) has not approved the microdevice a treatment for any disease. AACRF, a research foundation, is supporting this research study by providing funding for the research study, the study drugs and study procedures.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.