RecruitingEarly Phase 1NCT05553782

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

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


Sponsor

Brigham and Women's Hospital

Enrollment

30 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a tiny implanted device (about the size of a grain of rice) placed directly inside head and neck tumors to screen multiple cancer drugs and find which ones work best before surgery. The goal is to personalize treatment and improve outcomes. **You may be eligible if:** - You have been diagnosed with head and neck cancer (salivary gland, adenoid cystic carcinoma, or squamous cell carcinoma) - Your cancer has not spread and you are scheduled for surgery - You are 18 or older and otherwise healthy enough for the procedure - Your tumor measures at least 1 cm x 1 cm - Your blood counts and clotting levels are within acceptable ranges **You may NOT be eligible if:** - You are currently enrolled in another investigational drug trial - You have uncontrolled infections, heart problems, or psychiatric conditions that would make surgery unsafe - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTImplantable 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


Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT05553782


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