Trial Title:
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
NCT ID:
NCT05926765
Condition:
Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
Conditions: Official terms:
Xerostomia
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Genetic
Intervention name:
AAV2-hAQP1 Concentration 1
Description:
Administration of concentration 1 of AAV2-hAQP1 via Stensen's duct to each parotid gland
Arm group label:
AAV2-hAQP1 Group 1
Intervention type:
Genetic
Intervention name:
AAV2-hAQP1 Concentration 2
Description:
Administration of concentration 2 of AAV2-hAQP1 via Stensen's duct to each parotid gland
Arm group label:
AAV2-hAQP1 Group 2
Intervention type:
Other
Intervention name:
Placebo
Description:
Administration of diluent via Stensen's duct to each parotid gland
Arm group label:
Placebo group
Summary:
This study will assess the efficacy and safety of bilateral intra-parotid administration
of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Completed beam radiation therapy for head and neck cancer at least 3 years prior to
the first screening visit
- No history of parotid gland cancer, recurrent cancer, or a second primary cancer
- An unstimulated whole saliva flow rate (mL/min) >0 (i.e., at least one drop of
saliva in the collection tube)
- A stimulated whole saliva flow rate (mL/min) within a specified range after
mechanical stimulation by chewing
- Average screening XQ Total Score at or above a specified threshold
- No evidence of head and neck cancer, defined as a negative otolaryngology exam and a
negative computed tomography (CT) scan of the head, neck, and chest with contrast.
If a participant has had a magnetic resonance imaging (MRI) study, CT scan, positron
emission tomography (PET), or fluorodeoxyglucose-positron emission tomography
(FDG-PET) scan of the head, neck, and chest within 6 months of study entry (and at
least 3 years after the completion of radiotherapy), then that image may be used for
eligibility determination and a CT scan at screening will not be required.
- Either received treatment with one or more prescription sialagogues and elected to
discontinue therapy or, in consultation with their physician, elected to not
initiate such treatment
- Participants taking a prescription sialagogue (specifically, pilocarpine or
cevimeline) must stop that medication at least 2 weeks prior to Screening and be
willing to refrain from taking such medications for the duration of the study
- Participants who require medication for an underlying medical condition that is
known to affect salivary output must be on stable doses of such medications for at
least one month prior to the first screening visit
Exclusion Criteria:
- Any malignancy within the preceding 3 years, except for treated basal cell or
squamous cell carcinoma of the skin or in situ cervical carcinoma
- History of systemic autoimmune disease affecting the salivary glands (e.g.,
Sjogren's disease)
- Currently using systemic immunosuppressive medication(s) (e.g., corticosteroids or
biologics) or treated with one within 4 weeks of the first screening visit. Note:
Topical, inhaled, or intranasal corticosteroids are permitted.
- Active viral infection with Epstein-Barr virus (EBV), defined as a positive anti-VCA
IgM. In the event a potential participant has a positive anti-VCA IgM, they may be
rescreened 2-4 months later at which time a positive Epstein-Barr Virus Nuclear
Antigen (EBNA) will be considered as evidence of resolved EBV infection.
- Evidence of active Hepatitis C virus (HCV) infection
- Evidence of human immunodeficiency virus (HIV) infection
- Diagnosis of myasthenia gravis
- Personal or family history of acute or chronic angle-closure glaucoma (ACG), or at
increased risk of developing ACG, or had prophylactic treatment to reduce the risk
of developing ACG
- Known allergy or hypersensitivity to glycopyrrolate
- Current smokers or history of smoking within the preceding 3 years (includes vaping
with tobacco additives)
- Current alcohol misuse or a history of the same within the preceding 3 years
(defined for men as an average intake of more than 14 drinks per week and for women
as more than 7 drinks per week)
- Poorly controlled diabetes (hemoglobin A1c >7%)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Bennett II
Email:
David.BennettII@bannerhealth.com
Investigator:
Last name:
Walker, Dr
Email:
Principal Investigator
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ellie Maghami
Phone:
626-218-1133
Investigator:
Last name:
Maghami, Dr.
Email:
Principal Investigator
Facility:
Name:
Miami Cancer Institute at Baptist Health South Florida
Address:
City:
Miami
Zip:
33176
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alessandro Villa
Phone:
786-596-2000
Email:
Alessandro.villa@baptisthealth.net
Investigator:
Last name:
Alessandro Villa, Dr
Email:
Principal Investigator
Facility:
Name:
University of Iowa
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Kassem
Email:
amy-kassem@uiowa.edu
Investigator:
Last name:
Henry Hoffman, Dr.
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins Hospital
Address:
City:
Baltimore
Zip:
21231
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Leitzel
Email:
jvogel10@jhmi.edu
Investigator:
Last name:
Quon, Dr
Email:
Principal Investigator
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Daniel Gbujie
Email:
dgbujie@bwh.harvard.edu
Investigator:
Last name:
Herve Sroussi, Dr.
Email:
Principal Investigator
Facility:
Name:
Henry Ford Health
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Subramanian Karthikeyan
Phone:
313-725-7859
Email:
CCTROHandNTeam@hfhs.org
Investigator:
Last name:
Tam, Dr.
Email:
Principal Investigator
Facility:
Name:
University of Missouri
Address:
City:
Columbia
Zip:
65212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rebecca Schneider
Email:
schneiderri@health.missouri.edu
Investigator:
Last name:
Tassone, Dr
Email:
Principal Investigator
Facility:
Name:
Erie County Medical Center
Address:
City:
Buffalo
Zip:
14215
Country:
United States
Status:
Recruiting
Contact:
Email:
studyteam@ecmc.edu
Investigator:
Last name:
Frustino, Dr
Email:
Principal Investigator
Facility:
Name:
UNC-Chapel Hill
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yumika Forney
Phone:
919-962-8559
Email:
yumika_forney@med.unc.edu
Investigator:
Last name:
Chen, Dr.
Email:
Principal Investigator
Facility:
Name:
Atrium Health
Address:
City:
Charlotte
Zip:
28203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jenene Noll
Email:
jenene.noll@atriumhealth.org
Investigator:
Last name:
Michael Brennan, Dr.
Email:
Principal Investigator
Facility:
Name:
Penn State
Address:
City:
Hershey
Zip:
17033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carly Herbe
Phone:
717-531-6822
Email:
cherbe@pennstatehealth.psu.edu
Investigator:
Last name:
Goyal, Dr.
Email:
Principal Investigator
Facility:
Name:
Alleghany General Hospital
Address:
City:
Pittsburgh
Zip:
15212
Country:
United States
Status:
Recruiting
Contact:
Email:
clinicaltrials@ahn.org
Investigator:
Last name:
Swegal, Dr
Email:
Principal Investigator
Facility:
Name:
UT Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Thomas Schlieve, DDS, MD
Phone:
214-648-3034
Investigator:
Last name:
Schlieve, MD
Email:
Principal Investigator
Facility:
Name:
Houston Methodist
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Garrett
Phone:
346-238-4516
Email:
jmgarrett@houstonmethodist.org
Investigator:
Last name:
Moyhuddin, Dr.
Email:
Principal Investigator
Facility:
Name:
Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North
Address:
City:
Sudbury
Zip:
P3E 5J1
Country:
Canada
Status:
Recruiting
Contact:
Email:
hsnriclinicalresearch@hsnri.ca
Investigator:
Last name:
Saunders, Dr
Email:
Principal Investigator
Facility:
Name:
CIUSSS-MCQ (Trois-Rivières, QC)
Address:
City:
Trois-Rivières
Zip:
G8Z 3R9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Marie-Eve Caron
Phone:
819-697-3333
Phone ext:
63238
Email:
marie-eve_caron_chrtr@ssss.gouv.qc.ca
Investigator:
Last name:
Vincent, Dr.
Email:
Principal Investigator
Facility:
Name:
Addenbrooke's Hospital
Address:
City:
Cambridge
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Amy Bates
Email:
amy.bates9@nhs.net
Investigator:
Last name:
Man, Dr.
Email:
Principal Investigator
Facility:
Name:
Ninewells Hospital & Medical School
Address:
City:
Dundee
Zip:
DD1 9SY
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Janet Douglas
Phone:
01382 496685
Email:
tay.stefaniunit@nhs.scot
Investigator:
Last name:
Manickavasagam, Dr
Email:
Principal Investigator
Facility:
Name:
Western General
Address:
City:
London
Zip:
EH4 2XU
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Ashley Hay
Phone:
0131 536 3162
Email:
Ashley.Hay@nhs.scot
Investigator:
Last name:
Hay, Dr.
Email:
Principal Investigator
Facility:
Name:
Guys Hospital
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Daisy Hubble
Phone:
020 7188 2018
Email:
daisy.hubble@gstt.nhs.uk
Investigator:
Last name:
Guerrero-Urbano, Dr.
Email:
Principal Investigator
Facility:
Name:
Nottingham University Hospitals NHS Trust
Address:
City:
Nottingham
Zip:
NG7 2UH
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Jo Curtis
Phone:
01159249924
Phone ext:
80693
Email:
joanna.curtis3@nhs.net
Contact backup:
Last name:
Kirsty Topham
Email:
kirsty.topham2@nhs.net
Investigator:
Last name:
Simons, Dr.
Email:
Principal Investigator
Start date:
June 13, 2023
Completion date:
July 2025
Lead sponsor:
Agency:
MeiraGTx, LLC
Agency class:
Industry
Source:
MeiraGTx UK II Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05926765
