Safety Study of HPV DNA Vaccine to Treat Head and Neck Cancer Patients

PHASE1TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions
Head and Neck Cancer
Interventions
BIOLOGICAL

DNA Vaccine

Patients will receive intramuscular needle injections of pNGVL4a-CRT/E7 (detox) DNA vaccine using the TDS-IM device on Day 1, 22, and 43 for a total of three vaccinations per patient. One day prior to each DNA vaccination, the patient will receive a single low dose of 200 mg/m2 of cyclophosphamide intravenously. The DNA vaccine will be administered in a dose-escalating manner.

DRUG

Cyclophosphamide

A single low dose of 200 mg/m2 of cyclophosphamide (CTX) will be administered intravenously up to 24 hours (Day 0) prior to each DNA vaccination.

Trial Locations (1)

21287

Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital, Baltimore

Sponsors
All Listed Sponsors
collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

collaborator

Ichor Medical Systems Incorporated

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT01493154 - Safety Study of HPV DNA Vaccine to Treat Head and Neck Cancer Patients | Biotech Hunter | Biotech Hunter