Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers

Official title

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

Overview

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

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.

Interventions

• 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 treat

Primary outcome measures

• Grade 3 or Higher Treatment-Related Toxicity Rate [Time frame: AE assessed on post-operative visit, which take placed between 7-14 days after the surgical procedure.]

Secondary outcome measures (6)

• Pharmacodynamic (PD) [Time frame: Screening Period 1 day]
• Evaluate the likelihood of independent drug or combination response/failure in this pilot population to determine the appropriateness of nominating therapies for further clinical investigation [Time frame: through study completion, an average of 1 year]
• Tumor Response [Time frame: through study completion, an average of 1 year]
• Gene Expression Level [Time frame: through study completion, an average of 1 year]
• Changes in Tumor Metabolism [Time frame: through study completion, an average of 1 year]
• Biomarker levels [Time frame: through study completion, an average of 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Brigham and Women's Hospital — Boston
• Dana Farber Cancer Institute — Boston

Identifiers

NCT: NCT05553782 · 22-381

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗