Clinical Trials
Catherine Curtin, MD
A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia
Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in subjects with radiation-induced xerostomia The objectives are to evaluate the safety and identify either a maximum tolerated dose or a maximum feasible dose of a single dose of AAV2hAQP1 infused into one or both parotid glands:
To evaluate subject improvement of xerostomia symptoms, to evaluate the increase in parotid gland salivary output after treatment with AAV2hAQP1, to evaluate additional efficacy outcomes.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: AAV2hAQP1: 1 x 10^11 vg/gland (single gland)
- drug: AAV2hAQP1: 3 x 10^10 vg/gland (both glands)
- drug: AAV2hAQP1: 3 x 10^11 vg/gland (single gland)
- drug: AAV2hAQP1: 1 x 10^11 vg/gland (both glands)
- drug: AAV2hAQP1: 1 x 10^12 vg/gland (single gland)
- drug: AAV2hAQP1: 3 x 10^11 vg/gland (both glands)
- drug: AAV2hAQP1: 3 x 10^12 vg/gland (single gland)
- drug: AAV2hAQP1: 1 x 10^12 vg/gland (both glands)
Eligibility
Inclusion Criteria:
1. Male or female subjects ≥18 years of age.
2. History of radiation therapy for head and neck cancer.
3. 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.
4. 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.
5. 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.
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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Somayeh H. Ahmad
650-441-0405
Not Recruiting
Dyani Gaudilliere, MD
A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia
Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in subjects with radiation-induced xerostomia The objectives are to evaluate the safety and identify either a maximum tolerated dose or a maximum feasible dose of a single dose of AAV2hAQP1 infused into one or both parotid glands:
To evaluate subject improvement of xerostomia symptoms, to evaluate the increase in parotid gland salivary output after treatment with AAV2hAQP1, to evaluate additional efficacy outcomes.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: AAV2hAQP1: 1 x 10^11 vg/gland (single gland)
- drug: AAV2hAQP1: 3 x 10^10 vg/gland (both glands)
- drug: AAV2hAQP1: 3 x 10^11 vg/gland (single gland)
- drug: AAV2hAQP1: 1 x 10^11 vg/gland (both glands)
- drug: AAV2hAQP1: 1 x 10^12 vg/gland (single gland)
- drug: AAV2hAQP1: 3 x 10^11 vg/gland (both glands)
- drug: AAV2hAQP1: 3 x 10^12 vg/gland (single gland)
- drug: AAV2hAQP1: 1 x 10^12 vg/gland (both glands)
Eligibility
Inclusion Criteria:
1. Male or female subjects ≥18 years of age.
2. History of radiation therapy for head and neck cancer.
3. 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.
4. 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.
5. 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.
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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Somayeh H. Ahmad
650-441-0405
Not Recruiting
David Kahn, MD
A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia
Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in subjects with radiation-induced xerostomia The objectives are to evaluate the safety and identify either a maximum tolerated dose or a maximum feasible dose of a single dose of AAV2hAQP1 infused into one or both parotid glands:
To evaluate subject improvement of xerostomia symptoms, to evaluate the increase in parotid gland salivary output after treatment with AAV2hAQP1, to evaluate additional efficacy outcomes.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: AAV2hAQP1: 1 x 10^11 vg/gland (single gland)
- drug: AAV2hAQP1: 3 x 10^10 vg/gland (both glands)
- drug: AAV2hAQP1: 3 x 10^11 vg/gland (single gland)
- drug: AAV2hAQP1: 1 x 10^11 vg/gland (both glands)
- drug: AAV2hAQP1: 1 x 10^12 vg/gland (single gland)
- drug: AAV2hAQP1: 3 x 10^11 vg/gland (both glands)
- drug: AAV2hAQP1: 3 x 10^12 vg/gland (single gland)
- drug: AAV2hAQP1: 1 x 10^12 vg/gland (both glands)
Eligibility
Inclusion Criteria:
1. Male or female subjects ≥18 years of age.
2. History of radiation therapy for head and neck cancer.
3. 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.
4. 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.
5. 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.
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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Somayeh H. Ahmad
650-441-0405
Not Recruiting
Gordon Lee, MD
A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia
Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in subjects with radiation-induced xerostomia The objectives are to evaluate the safety and identify either a maximum tolerated dose or a maximum feasible dose of a single dose of AAV2hAQP1 infused into one or both parotid glands:
To evaluate subject improvement of xerostomia symptoms, to evaluate the increase in parotid gland salivary output after treatment with AAV2hAQP1, to evaluate additional efficacy outcomes.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: AAV2hAQP1: 1 x 10^11 vg/gland (single gland)
- drug: AAV2hAQP1: 3 x 10^10 vg/gland (both glands)
- drug: AAV2hAQP1: 3 x 10^11 vg/gland (single gland)
- drug: AAV2hAQP1: 1 x 10^11 vg/gland (both glands)
- drug: AAV2hAQP1: 1 x 10^12 vg/gland (single gland)
- drug: AAV2hAQP1: 3 x 10^11 vg/gland (both glands)
- drug: AAV2hAQP1: 3 x 10^12 vg/gland (single gland)
- drug: AAV2hAQP1: 1 x 10^12 vg/gland (both glands)
Eligibility
Inclusion Criteria:
1. Male or female subjects ≥18 years of age.
2. History of radiation therapy for head and neck cancer.
3. 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.
4. 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.
5. 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.
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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Somayeh H. Ahmad
650-441-0405
Not Recruiting
H. Peter Lorenz, MD
A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia
Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in subjects with radiation-induced xerostomia The objectives are to evaluate the safety and identify either a maximum tolerated dose or a maximum feasible dose of a single dose of AAV2hAQP1 infused into one or both parotid glands:
To evaluate subject improvement of xerostomia symptoms, to evaluate the increase in parotid gland salivary output after treatment with AAV2hAQP1, to evaluate additional efficacy outcomes.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: AAV2hAQP1: 1 x 10^11 vg/gland (single gland)
- drug: AAV2hAQP1: 3 x 10^10 vg/gland (both glands)
- drug: AAV2hAQP1: 3 x 10^11 vg/gland (single gland)
- drug: AAV2hAQP1: 1 x 10^11 vg/gland (both glands)
- drug: AAV2hAQP1: 1 x 10^12 vg/gland (single gland)
- drug: AAV2hAQP1: 3 x 10^11 vg/gland (both glands)
- drug: AAV2hAQP1: 3 x 10^12 vg/gland (single gland)
- drug: AAV2hAQP1: 1 x 10^12 vg/gland (both glands)
Eligibility
Inclusion Criteria:
1. Male or female subjects ≥18 years of age.
2. History of radiation therapy for head and neck cancer.
3. 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.
4. 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.
5. 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.
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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Somayeh H. Ahmad
650-441-0405
Not Recruiting
Arash Momeni, MD
A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia
Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in subjects with radiation-induced xerostomia The objectives are to evaluate the safety and identify either a maximum tolerated dose or a maximum feasible dose of a single dose of AAV2hAQP1 infused into one or both parotid glands:
To evaluate subject improvement of xerostomia symptoms, to evaluate the increase in parotid gland salivary output after treatment with AAV2hAQP1, to evaluate additional efficacy outcomes.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: AAV2hAQP1: 1 x 10^11 vg/gland (single gland)
- drug: AAV2hAQP1: 3 x 10^10 vg/gland (both glands)
- drug: AAV2hAQP1: 3 x 10^11 vg/gland (single gland)
- drug: AAV2hAQP1: 1 x 10^11 vg/gland (both glands)
- drug: AAV2hAQP1: 1 x 10^12 vg/gland (single gland)
- drug: AAV2hAQP1: 3 x 10^11 vg/gland (both glands)
- drug: AAV2hAQP1: 3 x 10^12 vg/gland (single gland)
- drug: AAV2hAQP1: 1 x 10^12 vg/gland (both glands)
Eligibility
Inclusion Criteria:
1. Male or female subjects ≥18 years of age.
2. History of radiation therapy for head and neck cancer.
3. 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.
4. 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.
5. 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.
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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Somayeh H. Ahmad
650-441-0405
Not Recruiting
Dung Nguyen, MD
A Phase 1 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia
Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen's duct to a single or both parotid glands in subjects with radiation-induced xerostomia The objectives are to evaluate the safety and identify either a maximum tolerated dose or a maximum feasible dose of a single dose of AAV2hAQP1 infused into one or both parotid glands:
To evaluate subject improvement of xerostomia symptoms, to evaluate the increase in parotid gland salivary output after treatment with AAV2hAQP1, to evaluate additional efficacy outcomes.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: AAV2hAQP1: 1 x 10^11 vg/gland (single gland)
- drug: AAV2hAQP1: 3 x 10^10 vg/gland (both glands)
- drug: AAV2hAQP1: 3 x 10^11 vg/gland (single gland)
- drug: AAV2hAQP1: 1 x 10^11 vg/gland (both glands)
- drug: AAV2hAQP1: 1 x 10^12 vg/gland (single gland)
- drug: AAV2hAQP1: 3 x 10^11 vg/gland (both glands)
- drug: AAV2hAQP1: 3 x 10^12 vg/gland (single gland)
- drug: AAV2hAQP1: 1 x 10^12 vg/gland (both glands)
Eligibility
Inclusion Criteria:
1. Male or female subjects ≥18 years of age.
2. History of radiation therapy for head and neck cancer.
3. 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.
4. 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.
5. 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.
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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Somayeh H. Ahmad
650-441-0405
Not Recruiting