A Phase I/II Trial of Cetuximab in Combination With Interleukin-12 Administered to Patients With Unresectable Primary or Recurrent Squamous Cell Carcinoma of the Head and Neck
I. To find a safe and tolerable interleukin (IL)-12 (recombinant interleukin-12) dose for
use in combination with cetuximab in patients with unresectable primary or recurrent
squamous cell carcinoma of the head and neck. (phase I) II. To determine the response rate
to the combination of IL-12 and cetuximab. (phase II)
I. To characterize the immunologic effects of IL-12 when administered in combination with
OUTLINE: This is a dose-escalation study of recombinant IL-12.
Patients receive cetuximab intravenously (IV) over 1-2 hours on day 1 and recombinant
interleukin-12 subcutaneously (SC) on days 2 and 5 beginning in course 2. Treatment repeats
every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Patients achieving clinical response or stable disease may continue with therapy until
After completion of study therapy, patients are followed up for 1 year.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of dose-limiting toxicity (DLT) incidents to determine the maximum tolerated dose (MTD) of IL-12, evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (phase I)
Ohio State University
United States: Food and Drug Administration
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