Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Adenoid Cystic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Adenoid Cystic Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Dermatologic Agents

Vinorelbine

Lenvatinib

Venetoclax

Carboplatin

Pembrolizumab

Axitinib

Cisplatin

Tretinoin

Newly diagnosed, localized ACC salivary 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

* 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 salivary 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: Lenvatinib, Axitinib, All trans retinoic acid (ATRA), Venetoclax, Pembrolizumab, Cisplatin, Carboplatin, Vinorelbine

Implantable Microdevice (IMD)

Glenn J. Hanna, M.D.

Glenn J Hanna, MD

Glenn Hanna, MD

Glenn J. Hanna, M.D

This research study is studying the effect of different drugs as possible treatments for adenoid cystic carcinoma (ACC), a type of head and neck cancer.

The name of the study intervention involved in this study is:

-implantable microdevice

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 salivary gland ACC patients undergoing definitive oncologic resection.

-This research study is a Pilot Study, which is the first-time investigators are examining this study device in ACC. The treatment received (surgery and/or chemotherapy) will be the normal standard-of-care treatment for ACC. However, 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 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.

Drug Screening Using Novel IMD in ACC and Salivary Cancers

Therapeutic Drug Screening Using a Novel Implantable Microdevice (IMD) in Adenoid Cystic Carcinoma (ACC) and Salivary Cancers: a Window of Opportunity Study

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

All grade 3 or higher adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation.

Pharmacodynamics reported based on dose/exposure efficacy and safety relationships, there are no clinically significant differences in efficacy and safety between pembrolizumab doses of 200 mg or 2 mg/kg every 3 weeks in patients with melanoma or NSCLC.

Tumor molecular profiling using a commercially available assay (CARIS® MI Profile) will be performed on pathology material from resection sent for permanent processing using cut unstained tissue slides, in post-operative visit up 14 days

Tumor molecular profiling using a commercially available assay (CARIS® MI Profile) will be performed on pathology material from resection sent for permanent processing using cut unstained tissue slides, in post-operative visit up to 14 Days

For hypothesis-generating biomarker discovery, genome-wide approaches looking at both established and novel candidate biomarkers may be able to identify new biomarkers exclusive to ACC

Spots Global Cancer Trial Database for implantable microdevice imd