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
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|ClinicalTrials.gov Identifier: NCT02446249|
Recruitment Status : Recruiting
First Posted : May 18, 2015
Last Update Posted : September 20, 2019
- 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 ]
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)|