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Safety and Efficacy of Radiation/Cetuximab Plus EGFR Antisense DNA for Head and Neck Squamous Cell Carcinoma

NCT00903461 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-02-15

No results posted yet for this study

Summary

The Epidermal Growth Factor Receptor (EGFR) is highly expressed in SCCHN and its overexpression is associated with poor patient outcome. EGFR is a promising target of anticancer therapy. We have developed EGFR antisense DNA as a safe and potentially efficacious treatment for SCCHN as shown in a previous phase I study conducted at the University of Pittsburgh. Cetuximab (Erbitux or C225) is a chimerized EGFR monoclonal antibody that has produced positive results in a phase III trial in SCCHN when added to radiation therapy and was approved by the FDA for the treatment of locally advanced SCCHN. Radiation plus cetuximab is considered a standard treatment, especially for patients who are not good candidates for chemotherapy. In the current study, we plan to evaluate the addition of intratumoral EGFR antisense DNA (EGFR AS) to standard radiation with concurrent cetuximab in patients.

Conditions

  • Carcinoma, Squamous Cell of Head and Neck
  • Squamous Cell Carcinoma of the Head and Neck
  • Squamous Cell Carcinoma, Head And Neck

Interventions

BIOLOGICAL

EGFR Antisense DNA

* Intratumoral EGFR AS injections weekly x 7 weeks (or less if there is no identifiable tumor), starting 2 weeks prior to radiation. The first EGFR AS injection must be given after cetuximab is administered. Subsequent EGFR AS injections can be given before or after cetuximab is administered. Injections will be in the primary and/or lymph nodes. One site will be injected per weekly session. If it is necessary the antisense injection can be scheduled within 1 business day of the original schedule date and then resume the original schedule * EGFR AS will be administered by direct intratumoral injection using direct visualization, endoscopy, or imaging-guidance (ultrasound) as clinically determined. The same lesion (primary tumor or lymph node) will be injected during treatment.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Julie Bauman, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-03-31
Completion
2016-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00903461 on ClinicalTrials.gov