Eligibility Details:
Inclusion Criteria:
1. Male or female subjects ≥18 years of age.
2. History of radiation therapy for head and neck cancer.
3. MD Anderson Symptom Inventory-Head and Neck module-dry mouth score >6.
4. 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.
5. No evidence of recurrence of the primary malignancy by an otolaryngology (ears, nose,
and throat [ENT]) assessment. Additionally, all subjects must be disease-free of head
and neck cancer for at least 5 years following the end of treatment at screening, with
the exception of subjects with a history of HPV+ OPC (base of tongue, oropharynx,
pharynx, soft palate, tonsil) who must be disease free for at least 2 years following
the end of treatment. Disease status will be determined by negative clinical
examinations and computed tomography (CT) scans of the neck and chest. If subjects
have had a magnetic resonance imaging (MRI) of the neck or a positron emission
tomography (PET) scan within 6 months of screening, then a CT scan is not required,
except for HPV+ OPC subjects who must have scans at 2 years post treatment.
6. Female subjects of childbearing potential (i.e., ovulating, pre-menopausal, and not
surgically sterile) and all male subjects must use a medically accepted contraceptive
regimen during their participation in the study and until all samples collected at 2
consecutive visits following AAV2hAQP1 administration are negative. Acceptable methods
of contraception for male subjects include the following:
- Condoms with spermicide. Acceptable methods of contraception for female subjects
include the following:
- Intrauterine device for at least 12 weeks prior to Screening.
- Hormonal contraception (oral, implant, injection, ring, or patch) for at least 12
weeks prior to Screening.
- Diaphragm used in combination with spermicide.
7. On stable medications (>2 months) for any underlying medical conditions at the time of
study drug administration.
Exclusion Criteria:
1. Pregnant or lactating women or women planning to become pregnant.
2. Any experimental therapy within 3 months before Day 1.
3. Active infection that requires the use of intravenous antibiotics and does not resolve
at least 1 week before Day 1.
4. Uncontrolled ischemic heart disease (i.e., unstable angina, evidence of active
ischemic heart disease on electrocardiogram [ECG]).
5. History of systemic autoimmune diseases affecting the salivary glands.
6. Use of systemic immunosuppressive medications (i.e., corticosteroids).
o Note: Topical, inhaled, or intranasal corticosteroids are allowed.
7. Malignancy, other than head and neck cancer, within the past 3 years, with the
exception of adequately treated basal cell or squamous cell carcinoma of the skin or
in situ cervical carcinoma.
8. Active infections including, Epstein-Barr virus (EBV), cytomegalovirus (CMV),
hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) infection.
9. White blood cell count <3000/μL, absolute neutrophil count <1500/μL, hemoglobin <10.0
g/dL, platelet count <100,000/μL, or absolute lymphocyte count ≤500/μL.
10. Alanine aminotransferase and/or aspartate aminotransferase >1.5 × the upper limit of
normal (ULN), alkaline phosphatase >1.5 × ULN, or total bilirubin >1.5 × ULN with any
elevation of liver enzymes.
11. Estimated glomerular filtration rate <60 mL/min/1.73 m2 using the Modification of Diet
in Renal Disease equation.
12. Active use of tobacco products as determined by self-reporting.
13. Allergy to iodine or shellfish, and thus unable to have sialographic evaluations.
14. Allergy or hypersensitivity to glycopyrrolate.
Pharmaceutical medication involved
Recruiting patients only
