Safety of a Single Administration of AAV2hAQP1, an Adeno-Associated Viral Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in People With Irradiation-Induced Parotid Salivary Hypofunction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02446249|
Recruitment Status : Recruiting
First Posted : May 18, 2015
Last Update Posted : November 6, 2020
- Radiation can cause the parotid salivary glands to make less saliva (dry mouth). This can cause problems like infections and tooth decay. Researchers hope a new drug can help people with dry mouth caused by radiation.
- To examine the safety of AAV2hAQP1 gene therapy. To see if the drug increases saliva in people whose parotid glands have had radiation.
- People at least 18 years of age with a history of radiation therapy for head and neck cancer.
Participants will be screened in 2 visits with:
- medical history
- physical exam
- saliva collections
- sialogram. A substance is injected in the parotid gland and X-rays are taken.
- non-drug infusion
- IV dose of glycopyrrolate to stop saliva
3-day hospital stay: Participants will get the gene infusion. The AAV2hAQP1 will be in a solution in a syringe. It will be slowly pushed through an opening into the gland inside your mouth.
10 outpatient visits over 3 years. These may include:
- repeats of screening tests
- blood and urine tests
- oral and head and neck exams, including a thin scope in the airway
- small piece of skin taken
- small piece of parotid tissue taken by either: a small video-scope in the parotid duct that also takes pictures or by a small needle guided by ultrasound
- scans. Participants lie in a machine or a scanner The machine may feel close to the body or face. . For some, a substance will be injected in a vein or put in the mouth.
- Participants will keep a diary about how they feel before and after the therapy.
- oral microbiome gingival and buccal swab
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Head and Neck Cancer Radiation Induced Xerostomia Salivary Hypofunction||Biological: AAV2hAQP1||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label, Dose-Escalation Study Evaluating the Safety of a Single Administration of an Adeno-Associated Virus Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in Individuals With Irradiation-Induced Parotid Salivary Hypofunction|
|Study Start Date :||May 4, 2015|
|Estimated Primary Completion Date :||November 1, 2022|
|Estimated Study Completion Date :||November 1, 2022|
Experimental: single arm dose escalation
single arm dose escalation
Infusion of gene therapy
- Safety of vector [ Time Frame: 36 months ]
- Efficacy of treatment [ Time Frame: 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446249
|Contact: Katherine Hall, R.N., MSNfirstname.lastname@example.org|
|Contact: John A Chiorini, Ph.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||John A Chiorini, Ph.D.||National Institute of Dental and Craniofacial Research (NIDCR)|