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Virus Therapy
Gene Therapy for Radiation-Induced Dry Mouth
Phase 1
Waitlist Available
Led By John A Chiorini, Ph.D.
Research Sponsored by MeiraGTx, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No evidence of recurrence of primary malignancy by otolaryngology (ENT) assessment
All patients must have been disease-free of head and neck cancer for at least 5 years, a status to be determined at pre-dose screening using negative clinical exams and PET and or CT imaging of the neck and chest
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study Summary
This trial is testing a gene therapy for dry mouth caused by radiation. The therapy involves infusing the gene AAV2hAQP1 into the parotid gland. The trial will test the safety of the therapy and whether it increases saliva production.
Who is the study for?
Adults who've had radiation therapy for head and neck cancer, resulting in dry mouth due to low saliva production from the parotid gland. They must be disease-free for at least 5 years (or 2 years if they had HPV positive oropharyngeal cancer), able to use barrier contraception, have no severe dental issues or allergies related to the trial, not smoke, and can stay in the hospital for 3-5 days.Check my eligibility
What is being tested?
The safety of AAV2hAQP1 gene therapy is being tested. This involves a one-time infusion into one parotid salivary gland through the mouth. The goal is to see if this treatment can increase saliva production in those affected by dry mouth after radiation therapy.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at the injection site, general discomfort, changes in taste sensation due to salivary flow alteration, and possible immune responses against the viral vector used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ENT doctor found no signs of my cancer coming back.
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I have been free from head and neck cancer for at least 5 years, confirmed by exams and imaging.
Select...
I am 18 years old or older.
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I've had radiation therapy for head/neck cancer with a high dose to my salivary gland.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of vector
Secondary outcome measures
Efficacy of treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: single arm dose escalationExperimental Treatment1 Intervention
single arm dose escalation
Find a Location
Who is running the clinical trial?
MeiraGTx, LLCLead Sponsor
4 Previous Clinical Trials
170 Total Patients Enrolled
MeiraGTx UK II LtdLead Sponsor
14 Previous Clinical Trials
704 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
300 Previous Clinical Trials
848,595 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease like Sjogren's, lupus, or type I diabetes that is stable.I do not have an active infection requiring IV antibiotics 1 week before starting.I have not had a lung infection in the last 3 weeks.I do not have uncontrolled heart problems like unstable angina or heart failure.My parotid ducts cannot be seen on a special imaging test.My diabetes is not under control (HbA1c > 10%).My ENT doctor found no signs of my cancer coming back.I had HPV positive throat cancer and finished my treatment over 2 years ago.My medications for other health issues have been stable for at least 2 months.My salivary gland imaging shows a blockage that could affect treatment delivery, and my parotid gland is larger than 2.5 mL.I don't have any new major health issues that could stop me from completing the study.I have not received any live vaccines in the last 4 weeks.I agree to use barrier methods of contraception until AAV2hAQP1 is not found in my tests.I am a woman who cannot have children and will use barrier methods of birth control during the trial.I do not have untreated severe dental issues or pre-cancerous mouth conditions.I use regular medication for asthma or COPD.I have been free from head and neck cancer for at least 5 years, confirmed by exams and imaging.I am 18 years old or older.I can stay in the hospital for 3-5 days for each treatment phase.I haven't had cancer (other than skin or early cervical cancer) in the last 3 years.I am not on any immune-suppressing drugs, except for creams.I've had radiation therapy for head/neck cancer with a high dose to my salivary gland.
Research Study Groups:
This trial has the following groups:- Group 1: single arm dose escalation
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.
What risks does AAV2hAQP1 present for individuals?
"Due to the limited clinical data supporting both safety and efficacy, AAV2hAQP1 was awarded a score of 1 on our team's rating scale."
Answered by AI
What is the current participant count for this medical experiment?
"Affirmative. The details on clinicaltrials.gov demonstrate that this medical trial, which was originally posted on May 4th 2015, is actively enrolling patients. Approximately 36 subjects must be recruited from a single site."
Answered by AI
Are there still recruitment opportunities for this research endeavor?
"Affirmative, the clinical trial's information on clinicaltrials.gov reveals that it is currently enrolling participants. This medical research was initially posted in May 2015 and has been updated more recently on May 3rd 2022. A total of 36 patients are needed from a single facility."
Answered by AI
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