Aerodigestive Precancerous Lesions and Malignancies Clinical Trial
Official title:
A Study of HPV Specific Immunotherapy in Subjects With HPV6 Associated Aerodigestive Precancerous Lesions and Malignancies
| NCT number | NCT02241369 |
| Other study ID # | HPV-006 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | May 2014 |
| Est. completion date | September 2018 |
| Verified date | November 2018 |
| Source | Inovio Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 with HPV6 associated aerodigestive precancerous lesions and malignancies.
| Status | Completed |
| Enrollment | 3 |
| Est. completion date | September 2018 |
| Est. primary completion date | September 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Inovio Pharmaceuticals | University of Pennsylvania |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Time to new anti-cancer therapy | First dose to Week 26 | ||
| Primary | Adverse events measured and graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03 | Up to 6 months | ||
| Primary | Injection site reactions including skin erythema, induration pain and tenderness at administration site | Up to 15 weeks | ||
| Secondary | HPV6 specific Ig levels | Up to 6 months | ||
| Secondary | Number of antigen-specific IFN-?-secreting cells in response to stimulation with HPV6 by antigen-specific IFN-? ELISpot assays | Up to 6 months | ||
| Secondary | Cytotoxic T cells in response to HPV6 specific immunotherapy by flow cytometry | Up to 6 months |