Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery
|Head and Neck Squamous Cell Carcinoma||Biological: Cetuximab Other: Laboratory Biomarker Analysis Biological: Recombinant Interleukin-12||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- Number of Dose-limiting Toxicity Incidents to Determine the Maximum Tolerated Dose of IL-12, Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I) [ Time Frame: 14 days ]
- Proportion of Patients Who Have Any Response to Treatment (Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors (Phase II) [ Time Frame: Up to 6 months ]The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
- Induction of Systemic Plasma Levels of Interferon-gamma [ Time Frame: Baseline up to day 50 ]Explores graphically how changes in this marker differ between those with versus without an objective response to therapy as well as other potential factors.
- Number of Confirmed Clinical Responses (Phase I) [ Time Frame: Up to 6 months ]Summarized by simple descriptive summary statistics.
- Overall Survival (Phase II) [ Time Frame: From the date of registration to date of death, assessed up to 1 year ]The Kaplan-Meier method will be used to estimate overall survival distribution.
- Proportion of Patients Who Are Progression-free (Phase I) [ Time Frame: 6 months ]Summarized by simple descriptive summary statistics.
- Time to Disease Progression (Phase II) [ Time Frame: From date of registration to date of progression, assessed up to 1 year ]The Kaplan-Meier method will be used to estimate time to progression distributions.
|Actual Study Start Date:||November 4, 2011|
|Estimated Study Completion Date:||January 2018|
|Primary Completion Date:||July 12, 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (cetuximab and recombinant interleukin-12)
Patients receive cetuximab IV over 1-2 hours on day 1 and recombinant interleukin-12 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.
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesBiological: Recombinant Interleukin-12
I. To find a safe and tolerable interleukin (IL)-12 (recombinant interleukin-12) dose for use in combination with cetuximab in patients with 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 cetuximab.
OUTLINE: This is a phase I, dose-escalation study of recombinant IL-12 followed by a phase II study.
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 treatment, patients are followed up for 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468896
|United States, District of Columbia|
|MedStar Georgetown University Hospital|
|Washington, D.C., District of Columbia, United States, 20007|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||William Carson||Ohio State University Comprehensive Cancer Center|