Radiation and Cetuximab Plus Intratumoral EGFR Antisense DNA in Locally Advanced Head and Neck Squamous Cell Carcinoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

February 1, 2022

Study Completion Date

February 1, 2022

Conditions
Squamous Cell CarcinomaHead and Neck Cancer
Interventions
BIOLOGICAL

EGFR Antisense DNA

EGFR AS will be administered by direct intratumoral injection using direct visualization, endoscopy, or imaging-guidance (ultrasound) as clinically determined. Patients will receive a total of up to 4 weekly intratumoral injections of EGFR antisense (or less if there is no identifiable tumor) starting 2 weeks prior to radiation. Patients will receive standard radiation 70 Gy/200 cGy/daily, 5 days/week, with concurrent cetuximab 250 mg/m2, after a loading dose of 400 mg/m2 2 weeks prior to starting radiation.

Trial Locations (2)

15213

University of Pittsburgh, Pittsburgh

78229

Cancer Therapy and Research Center at UTHSCSA, San Antonio

All Listed Sponsors
collaborator

University of Pittsburgh

OTHER

lead

The University of Texas Health Science Center at San Antonio

OTHER

NCT01592721 - Radiation and Cetuximab Plus Intratumoral EGFR Antisense DNA in Locally Advanced Head and Neck Squamous Cell Carcinoma | Biotech Hunter | Biotech Hunter