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IMD Drug Screening for Adenoid Cystic Carcinoma
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
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
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 moreTrial 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
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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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,102 Previous Clinical Trials
358,024 Total Patients Enrolled
Adenoid Cystic Carcinoma Research FoundationOTHER
6 Previous Clinical Trials
199 Total Patients Enrolled
Glenn J. Hanna, M.DPrincipal InvestigatorDana-Farber Cancer Institute
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses that would make surgery or biopsy unsafe.My initial biopsy suggests I might have ACC or a similar condition.I am 18 years old or older.My doctor says I'm fit for surgery and other procedures.I am not pregnant, as pregnancy excludes me from this study due to potential risks.I am a woman who can have children and have a recent negative pregnancy test.I am fully active or restricted in physically strenuous activity but can do light work.I have a bleeding or clotting issue that makes surgery risky.My tumor is at least 1cm big and can be seen on scans.I have a confirmed diagnosis of ACC in the salivary glands and am undergoing surgery.My tumor is at least 1 x 1 cm in size and can be measured by a doctor.
Research Study Groups:
This trial has the following groups:- Group 1: IMD PLACEMENT + SURGICAL RESECTION + ADJUVANT TREATMENT ARM
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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