Implantable Microdevice for Evaluating Drug Responses in Patients with Head and Neck Cancers, the Window of Opportunity Study

Status: active

This phase I trial investigates the safety and feasibility of an implantable microdevice for the evaluation of drug response in patients with head and neck cancers. This research study involves implanting and retrieving a small device, as small as the tip of a needle, and can release up to 20 approved cancer drugs into the tumor. This research study may help doctors find which drugs have better effects on treating tumors.

Inclusion Criteria

Participants must have histologically confirmed head and neck cancer (any histology) undergoing definitive surgical or systemic therapy as part of 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, prothrombin time (PT)/international normalized ratio (INR) < 2, and activated partial thromboplastin time (aPTT) < 1.5 x 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

PRIMARY OBJECTIVE:

I. To evaluate the safety and feasibility of microdevice placement and removal in head and neck cancer patients.

SECONDARY OBJECTIVES:

I. To conduct pharmacokinetic (PK) measurements of drug concentrations around microdevice reservoirs for twenty drugs across multiple therapeutic classes.

II. To perform pharmacodynamic (PD) measurements of tumor and microenvironment response to drugs, including apoptosis indices, immune infiltration, and markers of deoxyribonucleic acid (DNA) damage, using multiplexed immunohistochemistry.

III. To 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.

IV. To identify biomarkers of tumor response to drugs in head and neck cancers using an established commercially available clinical biomarker assay (comprised of DNA/ribonucleic acid (RNA) sequencing, fragment analysis, immunohistochemistry [IHC] and chromogenic in situ hybridization [ISH]).

V. To explore candidate genes and gene expression patterns correlating with resistance and response to drugs using single-cell RNA sequencing.

VI. To explore local changes in tumor metabolism effects triggered by tested drugs using matrix-assisted laser desorption/ionization (MALDI).

VII. To correlate responses and biomarkers with genomic profiling and clinical tumor phenotypes to build a genotype-phenotype dataset.

OUTLINE:

Patients undergo placement of 1-5 microdevices to receive standard of care drugs (lenvatinib, axitinib, tretinoin, venetoclax, pembrolizumab, nivolumab, cisplatin, carboplatin, vinorelbine, paclitaxel, docetaxel, fluorouracil, cetuximab) 3-5 days later patients then undergo standard of care surgery or retrieval of microdevices. Patients also undergo magnetic resonance imaging (MRI), computed tomography (CT) scan, and collection of blood samples throughout the trial.

After completion of study treatment, patients are followed every 4 months for up to 2 years.

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Implantable Microdevice for Evaluating Drug Responses in Patients with Head and Neck Cancers, the Window of Opportunity Study

Inclusion Criteria

Exclusion Criteria

United States

Massachusetts

Boston

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Implantable Microdevice for Evaluating Drug Responses in Patients with Head and Neck Cancers, the Window of Opportunity Study

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