Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372320
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2006-09-02
Brief Title:
Effect of AdhAQP1 on Salivary Flow in Patients Treated With Radiation for Head and Neck Cancer
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Open-Label Dose-Escalation Study Evaluating the Safety of a Single Administration of AdhAQP1 an Adenoviral Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in Individuals With Irradiation-Induced Parotid Salivary Hypofunction
Status:
COMPLETED
Status Verified Date:
2018-09-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine whether the experimental drug AdhAQP1 can increase salivary flow in patients whose parotid glands have been exposed to therapeutic radiation for treatment of head and neck cancer Radiation may damage the parotid glands salivary glands located under the skin in front of the ear leading to dry mouth infections excessive tooth decay mouth sores difficulty swallowing and pain AdhAQP1 contains the human aquaporin-1 gene which codes for a protein that works to transport water across cells and a virus that normally can cause colds in humans but is modified to render it ineffective In animal experiments AdhAQP1 has increased saliva production for a short time
Patients between 18 years of age or older who received radiation treatment for head and neck cancer at least 5 years before enrolling in this study who have no evidence of recurrent tumor who have dry mouth and who secrete abnormally low levels of saliva from the parotid glands may be eligible for this study Candidates are screened with a medical history physical examination blood urine and saliva tests electrocardiogram EKG chest x-ray MRI exam gallium scan a nuclear medicine test to look for inflammation in the salivary glands technetium pertechnetate scan a nuclear medicine test to examine salivary gland function parotid sialogram x-ray of parotid gland PET and CT scans to look for signs of tumor and a skin biopsy to collect skin cells for use in immunological tests
Participants have a salt and sugar solution infused through a catheter plastic tube into both parotid glands After 10 minutes the solution drains into the mouth and is swallowed Saliva is collected from the parotid glands at 6 and 24 hours after administration of the salt and sugar solution Ten to 14 days later patients are admitted to the NIH Clinical Center for up to 4 days for the following tests and procedures
On the first day administration through a catheter of the study drug AdhAQP1 into one parotid gland
Monitoring over the next 3 days for changes in patients ability to produce saliva This includes medical examinations and several blood urine and saliva collections
Technetium scan on day 2
Gallium scan on day 2
Patients return to NIH for follow-up visits at 1 2 4 and 6 weeks after the AdhAQP1 infusion and then 3 4 5 6 and 12 months for a medical examination and blood urine and saliva collections Gallium technetium and MRI scans are repeated at several of the follow-up visits and sialograms are done at 6 and 12 months Chest x-ray and EKG are repeated at 4 and 6 months
Patients between 18 years of age or older who received radiation treatment for head and neck cancer at least 5 years before enrolling in this study who have no evidence of recurrent tumor who have dry mouth and who secrete abnormally low levels of saliva from the parotid glands may be eligible for this study Candidates are screened with a medical history physical examination blood urine and saliva tests electrocardiogram EKG chest x-ray MRI exam gallium scan a nuclear medicine test to look for inflammation in the salivary glands technetium pertechnetate scan a nuclear medicine test to examine salivary gland function parotid sialogram x-ray of parotid gland PET and CT scans to look for signs of tumor and a skin biopsy to collect skin cells for use in immunological tests
Participants have a salt and sugar solution infused through a catheter plastic tube into both parotid glands After 10 minutes the solution drains into the mouth and is swallowed Saliva is collected from the parotid glands at 6 and 24 hours after administration of the salt and sugar solution Ten to 14 days later patients are admitted to the NIH Clinical Center for up to 4 days for the following tests and procedures
On the first day administration through a catheter of the study drug AdhAQP1 into one parotid gland
Monitoring over the next 3 days for changes in patients ability to produce saliva This includes medical examinations and several blood urine and saliva collections
Technetium scan on day 2
Gallium scan on day 2
Patients return to NIH for follow-up visits at 1 2 4 and 6 weeks after the AdhAQP1 infusion and then 3 4 5 6 and 12 months for a medical examination and blood urine and saliva collections Gallium technetium and MRI scans are repeated at several of the follow-up visits and sialograms are done at 6 and 12 months Chest x-ray and EKG are repeated at 4 and 6 months
Detailed Description:
The treatment of most head and neck cancer patients includes ionizing radiation IR Salivary glands in the IR field suffer irreversible damage There is no conventional treatment available to correct this condition Our research group has been developing the AdhAQP1 recombinant serotype 5 adenoviral rAd5 vector based on the hypothesis that a replication deficient rAd5 vector is capable of safely transferring the human aquaporin-1 hAQP1 cDNA to parotid glands of adult patients with IR-induced salivary hypofunction resulting in an elevated salivary output albeit transiently Salivary glands have proven to be valuable gene transfer targets in numerous pre-clinical animal model studies hAQP1 the archetypal water channel is a plasma membrane protein that facilitates water movement across lipid bilayers Rat and minipig studies have clearly shown that the AdhAQP1 strategy for restoring salivary flow to IR-damaged salivary glands is effective and studies in rats non-human primates and minipigs have shown that AdhAQP1 and similar rAd5 vectors are without significant untoward effects after salivary gland delivery The purpose of this clinical protocol is to test the safety of AdhAQP1 with some measures of efficacy in adult patients with established IR-induced parotid gland hypofunction The targeted tissue site for the AdhAQP1 vector in the proposed study is a single parotid gland In this Phase 1 dose-escalation study safety will be evaluated using conventional clinical and immunological parameters The primary outcome measure for biological efficacy will be parotid gland salivary output
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-D-0206 | None | None | None |