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
PRIMARY OBJECTIVES:
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)
SECONDARY OBJECTIVES:
I. To characterize the immunologic effects of IL-12 when administered in combination with
cetuximab.
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
disease progression.
After completion of study therapy, patients are followed up for 1 year.
Interventional
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)
14 days
Yes
William Carson
Principal Investigator
Ohio State University
United States: Food and Drug Administration
NCI-2011-03631
NCT01468896
October 2011
Name | Location |
---|---|
Ohio State University Medical Center | Columbus, Ohio 43210 |