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Monoclonal Antibodies
T-DM1 + Chemoradiation for Salivary Gland Cancer
Phase 2
Recruiting
Led By Glenn J Hanna, MD
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
Age 18 years or older
ECOG performance status ≤ 1 (Karnofsky ≥ 60%, see Appendix A)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months
Awards & highlights
Study Summary
This trial is studying T-DM1 and standard of care chemoradiation to see how well they work in treating patients with HER2-positive salivary gland cancer.
Who is the study for?
Adults with HER2-positive salivary gland cancer that can be surgically removed, and who haven't had prior HER2 therapy or chemotherapy/radiotherapy for head and neck cancer. They must have good organ function, not be pregnant or breastfeeding, willing to provide tissue and blood samples, and able to sign consent. Men must use effective contraception.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Ado-trastuzumab emtansine (T-DM1) combined with standard chemoradiation in treating resectable HER2-positive salivary gland carcinomas. It also looks at T-DM1's impact on preventing cancer recurrence.See study design
What are the potential side effects?
Possible side effects include liver issues, heart problems like reduced pumping ability, low blood cell counts leading to increased infection risk or bleeding problems, fatigue, nausea, infusion-related reactions, and potential harm to an unborn baby.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am mostly self-sufficient and can carry out daily activities.
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My salivary gland cancer is advanced but can be surgically removed.
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My cancer is HER2 positive.
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My heart's pumping ability is confirmed to be normal before starting treatment.
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My cancer has a high level of HER2 according to a specific test.
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My tumor shows a HER2 intensity of 2 or 3+.
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My cancer has a specific HER2 or ERBB2 mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease
Secondary outcome measures
Adverse Events
Distant metastatic-free survival (DMFS) Rate
Overall survival (OS) Rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Standard of Care + T-DM1 in HER2-Positive Salivary Gland CancerExperimental Treatment3 Interventions
Participants will undergo standard of care surgery followed by standard of care radiation and chemotherapy with the addition of T-DM1.
Study cycles are 21 days (3 weeks):
Participants will be given the study treatment T-DM1 at a predetermined dose (3.6 mg/kg) intravenously once (1x) every 3 weeks for up to 52 weeks (or about 1 year).
Participants will be given standard of care radiation and chemotherapy
Radiation will be given on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, and Cycle 3 Day 1
Chemotherapy (cisplatin 40 mg/m2 intravenously or carboplatin AUC 2 intravenously) will be given on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, and Cycle 3 Day 1
Participants will be followed for 3 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care Chemotherapy
2014
Completed Phase 2
~270
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,088 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,926 Total Patients Enrolled
Glenn J Hanna, MDPrincipal InvestigatorDana-Farber Cancer Institute
4 Previous Clinical Trials
72 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am mostly self-sufficient and can carry out daily activities.I do not have any severe illnesses that would stop me from following the study's requirements.My salivary gland cancer is advanced but can be surgically removed.My cancer is HER2 positive.My kidney function, measured by creatinine levels, is normal or nearly normal.I will use effective birth control during and for 6 months after the trial if I'm a man with a partner who can get pregnant.My heart's pumping ability is confirmed to be normal before starting treatment.I do not have any active or uncontrolled infections.I am a woman who can have children and have a recent negative pregnancy test.My cancer has a high level of HER2 according to a specific test.I had skin cancer or early-stage cervical/prostate cancer treated curatively, or any cancer in remission for 2 years.I have received radiation or chemotherapy for head and neck cancer.My cancer is either at an early stage, very advanced, or cannot be removed by surgery.I have received treatments specifically targeting HER2 in the past.I have another cancer that is getting worse or needs treatment.I am willing to give tissue and blood samples for the study.My organ and bone marrow functions are normal.My tumor shows a HER2 intensity of 2 or 3+.My cancer has a specific HER2 or ERBB2 mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care + T-DM1 in HER2-Positive Salivary Gland Cancer
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.
Are there any opportunities for participation in this trial at the moment?
"Affirmative, the clinicaltrials.gov database evidences that this medical trial is presently recruiting patients. Originally posted on December 24th 2020, it seeks 55 participants from 2 sites for enrollment."
Answered by AI
In what ways has Ado-trastuzumab (T) emtansine (T-DM1) been deployed therapeutically?
"Ado-trastuzumab (T) emtansine (T-DM1) is a frequent choice for initial treatment of various ailments, including advanced thymoma, testicular cancer, carcinoma and neuroendocrine diseases."
Answered by AI
Are there any precedents of Ado-trastuzumab (T) emtansine (T-DM1) being tested in past clinical trials?
"At present, 1173 research trials on Ado-trastuzumab (T) emtansine (T-DM1) are currently in progress. Of those tests, 388 have reached the third phase of experimentation. While this medication is primarily studied within Shanghai's confines, there are 70975 distinct sites where studies for T-DM1 can be found."
Answered by AI
What is the maximum participant capacity for this research endeavor?
"Affirmative. Clinicaltrials.gov states that since the study's December 24th 2020 inception, it has been actively recruiting 55 individuals from two distinct medical centres. The trial was last updated on December 27th 2021."
Answered by AI
What potential risks have been associated with Ado-trastuzumab (T) emtansine (T-DM1)?
"Ado-trastuzumab (T) emtansine (T-DM1)'s safety was initially assessed by our team at Power and assigned a score of 2. This rating is due to the medication being in Phase 2 trials, which suggests there has been limited data supporting efficacy but some evidence of it's security."
Answered by AI
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