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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT05553782
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Adenoid Cystic Carcinoma of the Salivary Gland
  • Head and Neck Cancer
  • Salivary Gland Cancer
  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Implantable Microdevice (IMD) — COMBINATION_PRODUCT
    * 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

Study Details

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

Key Dates

Start date
Nov 1, 2023
Status verified
Jan 2026
Primary completion
Apr 1, 2029
Completion
Aug 1, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

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. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Glenn J Hanna, MD
[email protected]
617-632-3090
Glenn J Hanna, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Glenn Hanna, MD
[email protected]
617-632-3090
Glenn Hanna, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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