Status:
COMPLETED
Immunotherapy in Subjects With HPV-6 Associated Aerodigestive Precancerous Lesions and Malignancies
Lead Sponsor:
Inovio Pharmaceuticals
Collaborating Sponsors:
University of Pennsylvania
Conditions:
Aerodigestive Precancerous Lesions and Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I, open-label study to evaluate the safety, tolerability, and immunogenicity of INO-3106 alone or in combination with INO-9012 DNA vaccines delivered by Electroporation to subjects wit...
Detailed Description
This is a Phase I, open-label, study to evaluate the safety, tolerability, and immunogenicity of 3 mg or 6 mg INO-3106 alone or in combination with 1 mg of INO-9012 (DNA plasmid encoding human interle...
Eligibility Criteria
Inclusion
- Signed and dated written Ethics Committee approved informed consent
- Age ≥18 years
- Histologically documented HPV-6 positive aerodigestive invasive malignancy (mucosal squamous cell head and neck cancer or lung cancer) who have completed therapies such as radiation/chemoradiation/chemotherapy; or
- Histologically documented HPV-6 positive papilloma or HPV-6 related premalignant lesion (i.e., carcinoma in situ) in aerodigestive or head and neck regions.
- Prior to study entry, subjects will have exhausted all treatments that are/have been used in these indications which may include any combination of surgery, anti-viral therapy, chemotherapy and/or radiation therapy.
- Core biopsy must be obtained prior to enrollment to confirm invasive cancer. Archival material is allowed.
- Adequate bone marrow, hepatic, and renal function. ANC (Absolute Neutrophil Count) ≥ 1.5x109 cell/ml, platelets ≥75,000 cells/mm3, hemoglobin ≥ 9.0 g/dL, concentrations of total serum bilirubin within 1.5 x upper limit of normal (ULN), AST, ALT within 2.5x ULN, CPK within 2.5 x ULN, serum creatinine ≤ 1.5x ULN
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2
Exclusion
- Participation in a clinical trial within 30 days before entry
- Any cardiac pre-excitation syndromes, e.g. Wolff-Parkinson-White syndrome
- Presence of metal implants within 5 cm of the planned site(s) of injection
- Anticipated concomitant immunosuppressive therapy (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids)
- Administration of any vaccine within 6 weeks of enrollment
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02241369
Start Date
May 1 2014
End Date
September 1 2018
Last Update
November 16 2018
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104