A Study of VGX-3100 and INO-9012 DNA Vaccine With Electroporation in Patients With Cervical Cancer
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Cervical cancer, Papillomavirus, Chemoradiation
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: 1.1 mL of VGX-3100 and INO-9012 delivered via IM EP Type: Biological
Name: Concurrent chemoradiation Type: Radiation
Overall Status
Recruiting
Summary
This is an open-label study to evaluate the safety, tolerability, and immunogenicity of VGX-3100 and INO-9012 DNA vaccines delivered by Electroporation to female subjects with HPV-16 or 18-positive cervical carcinoma.
Detailed Description
This is an open-label study to evaluate the safety, tolerability, and immunogenicity of 6 mg of VGX-3100 (2 separate DNA plasmids 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) female subjects with biopsy-proven HPV-16 or 18-positive, Stage IB-IVB inoperable intact invasive cervical carcinoma with 5 or fewer sites of metastatic disease treated with curative intent.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Written informed consent in accordance with institutional guidelines.

- Female subjects age 18-70 years;

- Histologically confirmed HPV-16 or -18 -positive Stage IB-IVB inoperable - invasive cervical carcinoma, inoperable intact cervix with 5 or fewer sites of metastatic disease;

- Adequate bone marrow, hepatic, and renal function: ANC (absolute neutrophil count) ≥ 1.5 x 10^9 cells/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 and ALT within 2.5 x institutional ULN, CPK within 2.5 x ULN performed within 2 weeks (±2 days) prior to start of chemoradiation and no more than 2 weeks prior to Day 0 immunotherapy dose;

- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1;

- Completion of standard radiation therapy within 10 weeks of its initiation and completion of 5 weekly courses of cisplatin at 40 mg/m2 within 10 weeks of its initiation

Exclusion Criteria:

- Previously treated cervical cancer;

- Lymphocyte count < 1.5 x10^9/L at screening;

- Prior major surgery within 4 weeks of randomization from which the patient has not yet recovered;

- High medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection;

- Current malignancies at other sites, with the exception of adequately treated basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the study;

- Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/ IV cardiac disease (refer to Appendix 9);

- Any concurrent condition requiring the continued use of systemic or topical steroids at or near the injection site, excluding non-systemic (e.g. inhaled and eye drop-containing) corticosteroids or the use of other immunosuppressive agents. All other corticosteroids must be discontinued > 4 weeks prior to Day 0 of study product administration;

- Any cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);

- History of seizures (unless seizure free for 5 years);
Locations
University of Chicago Medical Center
Chicago, Illinois, United States
Status: Recruiting
Contact: Fauzia Arif - 773-702-2856 - farif@radonc.uchicago.edu
University of Chicago Medical Center Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
Status: Recruiting
Contact: Fauzia Arif - 773-702-2856 - farif@radonc.uchicago.edu
University of Michigan
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Shaneta Waddy - 734-936-9439 - scotton@med.umich.edu
Columbia University Medical Center
New York, New York, United States
Status: Recruiting
Contact: Reena Vattakalam, CCRP - 212-342-6895 - rmv2110@cumc.columbia.edu
Start Date
May 2014
Completion Date
April 2017
Sponsors
Inovio Pharmaceuticals
Source
Inovio Pharmaceuticals
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page