What side effects are associated with this type of intervention?

Common treatments for Adenoid Cystic Carcinoma (ACC) include chemoradiotherapy with agents like carboplatin and paclitaxel. Known side effects of these treatments can include severe mucosal reactions, nausea, vomiting, and hematologic toxicities such as neutropenia and thrombocytopenia. Investigational localized drug delivery methods, such as the implantable microdevice, aim to minimize systemic side effects by delivering drugs directly to the tumor site, potentially reducing the severity of these adverse effects.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Adenoid Cystic Carcinoma (ACC) mentioned in the provided context. However, investigational approaches for ACC include targeted therapies such as c-kit TKIs (imatinib, dasatinib), mTOR inhibitors (everolimus), and proteasome inhibitors (bortezomib), which have shown minimal activity or stable disease in clinical trials. The Implantable Microdevice being studied aims to deliver drugs locally, which is a novel approach not yet reflected in current FDA approvals for ACC.

What other types of research exist?

Promising novel alternatives to Implantable Microdevice for Adenoid Cystic Carcinoma patients include: 1) c-kit Tyrosine Kinase Inhibitors (TKIs) such as imatinib and dasatinib, although they have shown minimal activity. 2) mTOR inhibitors like everolimus, which have demonstrated tumor burden reduction. 3) Proteasome inhibitors such as bortezomib, which have shown stable disease outcomes. 4) NOTCH inhibitors, with ongoing phase II trials evaluating their efficacy. These alternatives represent targeted therapies that are currently under investigation and may offer new treatment options for ACC patients.

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IMD Drug Screening for Adenoid Cystic Carcinoma

Q: What is the mechanism of action of this treatment?

The most common treatments for Adenoid Cystic Carcinoma (ACC) include localized drug delivery via implantable microdevices, c-kit tyrosine kinase inhibitors (TKIs) like imatinib and dasatinib, mTOR inhibitors such as everolimus, and proteasome inhibitors like bortezomib. These treatments target specific molecular pathways involved in ACC, such as the c-kit protein, mTOR pathway, and NF-KB pathway, aiming to increase efficacy and reduce systemic side effects. This targeted approach is crucial for ACC patients as it can potentially improve treatment outcomes and quality of life by directly addressing the mechanisms driving tumor growth and survival.

Phase < 1

Waitlist Available

Led By Glenn J. Hanna, M.D

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a tiny device that releases multiple drugs directly into tumors in patients with a specific type of head and neck cancer. The device helps doctors find out which drugs are most effective by analyzing it after it is removed during surgery.

Who is the study for?

This trial is for adults over 18 with adenoid cystic carcinoma of the salivary glands, who are fit for surgery and have a tumor at least 1 cm in size. They must not be pregnant, on other experimental drugs, or have serious illnesses that could risk biopsy/surgery safety.

What is being tested?

The study tests an implantable microdevice (IMD) to screen different drugs' effects on head and neck cancer. It's designed to see which treatments might work best for patients with adenoid cystic carcinoma.

What are the potential side effects?

Potential side effects aren't specified but may include risks associated with surgical procedures such as infection, bleeding, or reaction to anesthesia; plus any drug-specific reactions once identified by the IMD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Grade 3 or Higher Treatment-Related Toxicity Rate

Secondary study objectives

Biomarker levels

Changes in Tumor Metabolism

Gene Expression Level

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: IMD PLACEMENT + SURGICAL RESECTION + ADJUVANT TREATMENT ARMExperimental Treatment1 Intervention

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Adenoid Cystic Carcinoma (ACC) include localized drug delivery via implantable microdevices, c-kit tyrosine kinase inhibitors (TKIs) like imatinib and dasatinib, mTOR inhibitors such as everolimus, and proteasome inhibitors like bortezomib. These treatments target specific molecular pathways involved in ACC, such as the c-kit protein, mTOR pathway, and NF-KB pathway, aiming to increase efficacy and reduce systemic side effects. This targeted approach is crucial for ACC patients as it can potentially improve treatment outcomes and quality of life by directly addressing the mechanisms driving tumor growth and survival.

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