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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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: November 8, 2011
Last updated: December 13, 2016
Last verified: December 2016
This phase I/II trial studies the side effects and best dose of recombinant interleukin-12 when given together with cetuximab and to see how well they work in treating patients with squamous cell carcinoma of the head and neck that has come back, spread to another place in the body, or cannot be removed by surgery. Recombinant interleukin-12 may stimulate the white blood cells to kill tumor cells. Monoclonal antibodies, such as cetuximab, may interfere with the ability of tumor cells to grow and spread. Giving recombinant interleukin-12 together with cetuximab may kill more tumor cells.

Condition Intervention Phase
Head and Neck Squamous Cell Carcinoma
Biological: Cetuximab
Other: Laboratory Biomarker Analysis
Biological: Recombinant Interleukin-12
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 23
Study Start Date: October 2011
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Cetuximab
Given IV
Other Names:
  • Chimeric Anti-EGFR Monoclonal Antibody
  • Chimeric MoAb C225
  • Chimeric Monoclonal Antibody C225
  • Erbitux
  • IMC-C225
Other: Laboratory Biomarker Analysis
Correlative studies
Biological: Recombinant Interleukin-12
Given SC
Other Names:
  • Cytotoxic Lymphocyte Maturation Factor
  • IL-12
  • Interleukin 12
  • Interleukin-12
  • Natural Killer Cell Stimulatory Factor
  • NM-IL-12
  • Recombinant human interleukin-12 (IL-12) cytokine
  • Ro 24-7472

Detailed Description:


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have histologically-proven recurrent and/or metastatic squamous cell carcinoma of the head and neck that is unresectable; patients in the phase II portion of the trial must have measurable disease
  • Any number of prior systemic therapies for metastatic/recurrent disease are permitted in both the phase I and II portions of the study; patients need not have received a prior cetuximab-based chemotherapy regimen to be eligible for this trial
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Life expectancy of greater than 6 months
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 times upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients may not be receiving any other investigational agents
  • Patients with known brain metastases may be enrolled if this site of disease has been adequately treated, the patient does not require steroids, and the patient has been stable for at least 3 months prior to enrollment
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to IL-12 or other agents used in study
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with IL-12; these potential risks may also apply to other agents used in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01468896

United States, District of Columbia
MedStar Georgetown University Hospital
Washington, 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
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: William Carson Ohio State University Comprehensive Cancer Center
  More Information

Responsible Party: National Cancer Institute (NCI) Identifier: NCT01468896     History of Changes
Other Study ID Numbers: NCI-2011-03631  NCI-2011-03631  11010  2011C0019  CDR0000715306  OSU 11010  8860  N01CM00070  P30CA016058  U01CA076576  UM1CA186712 
Study First Received: November 8, 2011
Last Updated: December 13, 2016

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors processed this record on February 23, 2017