NCT02446249Befejeződött1. fázis

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

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 24.

Rövid összefoglaló (regiszter, angolul)

Background: \- 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. Objectives: \- To examine the safety of AAV2hAQP1 gene therapy. To see if the drug increases saliva in people whose parotid glands have had radiation. Eligibility: \- People at least 18 years of age with a history of radiation therapy for head and neck cancer. Design: Participants will be screened in 2 visits with: * medical history * physical exam * scans of the head, neck, and chest * intravenous administration of glycopyrrolate to stop saliva * saliva collections * sialogram which is a procedure in which a substance is injected in the parotid gland and X-rays are taken. * non-drug infusion * a small piece of skin being taken 3-5-day hospital stay: Participants will receive the gene infusion. The AAV2hAQP1 will be in a solution in a syringe. It will be slowly pushed into the parotid gland through the parotid duct, an opening in the mouth near the second upper molar tooth. 10 outpatient visits over 3 years. These may include: * repeats of selected screening tests, including saliva collection * blood and urine tests * oral and dental examinations * head and neck exams, including the use of a thin scope to see the back of the throat * questionnaires * a small piece of parotid tissue being taken by either a small scope through the parotid duct or by a small needle guided by ultrasound * scans of the head and neck. For some, contrast will be injected in a vein * completion of a diary about how the participant feels between visits * swabs of teeth and gums to assess the microbiome of the mouth

Állapot (regiszter): Befejeződött
Fázis (regiszter): 1. fázis
Vizsgálattípus: Beavatkozással járó
Résztvevők száma: 17 (tényleges)
Első benyújtás: 2015. máj. 14.
Kezdés: 2015. máj. 4.
Elsődleges befejezés: 2026. aug. 10.
Fő szponzor: MeiraGTx, LLC
Betegségek: Fej-nyaki daganatok
NCT-szám: NCT02446249

Mit vállalsz

Vizsgálat típusa: Beavatkozással járó · 1. fázis
Bevont résztvevők: 17
2015. máj. 4. és az elsődleges befejezés (2026. aug. 10.) között
1 helyszín, 1 országban
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Korábbi kezelés

Any experimental therapy within 3 months.
Any active respiratory tract infection in the 3 weeks prior to day 1 of the protocol
Active infection that requires the use of intravenous antibiotics and does not resolve at least 1 week before Day 1.
Use of systemic immunosuppressive medications (,i.e., corticosteroids). Topical corticosteroids are allowed.
Significant concurrent or recently diagnosed (\<2 months) medical condition that, in the opinion of the Medically Responsible Investigator, could affect the patient's ability to tolerate or complete the study.
Live vaccines within 4 weeks of first infusion.

Más betegség

Asthma or chronic obstructive pulmonary disease requiring regular inhaled or systemic corticosteroids.
Individuals with a history of autoimmune diseases affecting salivary glands, including Sjogren's syndrome, lupus, scleroderma, type I diabetes, sarcoidosis, amyloidosis, and chronic graft versus host disease. Organ specific autoimmune conditions may be included if clinically stable.
Malignancy, other than head and neck, within past 3 years, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma.
Active infections including Epstein-Barr virus (EBV), cytomegalovirus (CMV), hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
Individuals who have an allergy to iodine or shellfish and thus are unable to have sialographic evaluations.
Individuals who have an allergy or hypersensitivity to glycopyrrolate
Individuals with untreated severe dental caries, pyorrhea, gingivitis, chronic radiation mucositis or ulceration, erythroplasia, leukoplakia or other pre-malignant conditions.

Laborértékek

Pregnant or lactating women. Women of childbearing potential are required to have a negative serum pregnancy test at screening and a negative urine pregnancy test within 48 hours prior to gene infusion.
Uncontrolled ischemic heart disease: unstable angina, evidence of active ischemic heart disease on ECG, congestive heart failure (left ventricular ejection fraction \< 45% on MUGA or echo) or cardiomyopathy.
WBC \<3000/microL or ANC \<1500/microL or Hgb \<10.0 g/dL or platelets \<100,000/microL or absolute lymphocyte count less than or equal to 500/microL.
ALT and/or AST \> 1.5 times upper limit of normal (ULN) or alkaline phosphatase \>1.5 times ULN
Serum creatinine \> 2 mg/dL.
Serum bilirubin measurements (total, direct, indirect) that are outside of the normal range.
Individuals with uncontrolled diabetes (HbA1c greater than 10%).

Egyéb

Individuals who are active cigarette smokers as determined by self-reporting.
Individuals whose parotid duct(s) are not clinically accessible on screening sialography.
Individuals, who on sialography, have a distal stenosis that would impede vector delivery and, for the expansion cohort, those who have a parotid volume \>2.5 mL.
Individuals who have had an adverse response to prednisone (i.e. hallucinations).

A regiszterben nem jelölt feltételek

INCLUSION CRITERIA:
- At least 18 years of age
- History of external beam radiation therapy for head and neck cancer, with a mean dose equal to or greater than 15 Gy to a parotid gland.
- Abnormal parotid gland function as judged by both absence of unstimulated parotid salivary flow and a stimulated parotid salivary flow in the targeted parotid gland \>0 and \<0.3 mL/min/gland after 2% citrate stimulation.
- No evidence of recurrence of primary malignancy by otolaryngology (ENT) assessment. Additionally, 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. The anatomic subset of HPV positive oropharyngeal cancer may be enrolled after 2 years post completion of therapy.
- Willingness to practice the required birth control method ("barrier" contraception, condoms, diaphragm) until AAV2hAQP1 is no longer detectable in their serum or saliva.
- Women who cannot bear children (post-menopausal or due to a surgical intervention) also will be required to practice barrier birth control methods until AAV2hAQP1 is no longer detectable in their serum or saliva.
- Ability to stay at the NIH hospital for the period of time necessary to complete each on-site phase of the protocol (3-5 days).
- No history of allergies to any medications or agents to be used in this protocol.
- On stable medications (greater than or equal to 2 months) for any underlying medical conditions at time of vector administration.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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Helyszín	Város	Ország	Helyszín állapota
National Institutes of Health Clinical Center, 9000 Rockville Pike Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát	Bethesda	Egyesült Államok	Ismeretlen állapot

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