Study of HPV Specific Immunotherapy in Patients With HPV Associated Head and Neck Squamous Cell Carcinoma
Conditions
Head and Neck Squamous Cell Cancer
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms - Neoplasms, Squamous Cell
Conditions: Keywords
Head and neck squamous cell cancer, Papillomavirus
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: 1.1 mL of VGX-3100 and INO-9012 delivered via IM EP
Type: Biological
Overall Status
Recruiting
Summary
This is a Phase I/IIa, open-label study to evaluate the safety, tolerability, and immunogenicity of VGX-3100 and INO-9012 DNA vaccines delivered by Electroporation to subjects with HPV16 and HPV18 associated head and neck squamous cell cancer.
Detailed Description
This is a Phase I/IIa, open-label, study to evaluate the safety, tolerability, and immunogenicity of 6 mg of VGX-3100 (2 separate DNA plasmids respectively encoding E6 and E7 proteins of HPV 16 and HPV 18) and 1 mg of INO-9012 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in 20 (twenty) subjects with HPV-16 and/or 18-positive head and neck cancer. The immunotherapy will be studies in two groups of subjects (10 subjects in each group):

1. Subjects who will receive immunotherapy before and after surgery (Cohort I)

2. Subjects who will receive immunotherapy after concurrent chemoradiation therapy (Cohort II).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Signed and dated written Ethics Committee approved informed consent.

2. Age ≥18 years.

3. Histologically documented HPV-positive (as assessed by p16 IHC or oncogenic HPV ISH or PCR) mucosal squamous cell head and neck cancer. Core biopsy must be obtained prior to enrollment.

4. 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 institutional ULN, CPK within 2.5 x ULN.

5. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.

Exclusion Criteria:

1. Anticipated concomitant immunosuppressive therapy (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids).

2. Any concurrent condition requiring the continued use of systemic steroids (>10 mg prednisone or equivalent per day) or the use of immunosuppressive agents. All other corticosteroids must be discontinued at least 4 weeks prior to Day 0 of treatment.

3. Administration of any vaccine within 6 weeks of enrollment.
Location
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Mary Carberry - 215-614-1813 - mary.carberry@uphs.upenn.edu
Start Date
June 2014
Completion Date
December 2017
Sponsors
Inovio Pharmaceuticals
Source
Inovio Pharmaceuticals
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page