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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
Study Summary
This trial is studying the side effects of different drugs given together as possible treatments for adenoid cystic carcinoma (ACC), a type of head and neck cancer.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Grade 3 or Higher Treatment-Related Toxicity Rate
Secondary outcome measures
Biomarker levels
Changes in Tumor Metabolism
Therapeutic procedure
+3 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
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,928 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would any participants be welcomed to join this clinical experiment at present?
"The data on clinicaltrials.gov reveals that this medical trial is not presently seeking participants, as the study was initially published 11/1/2023 and most recently revised 9/22/2022. Nevertheless, there are currently 2475 other trials recruiting patients."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
What site did they apply to?
Dana Farber Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
Can you share more background information on what your proposing to test? How long will the treatment process take? How often do you need to follow up to collect data from me post treatment?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I realize that this rare type of cancer is in need of finding better treatment options. If the proposed treatment has potential to making a step forward on finding a treatment then I am willing to give it a try.
PatientReceived 2+ prior treatments
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