Overview

This trial is active, not recruiting.

Condition head and neck squamous cell carcinoma
Treatments cetuximab, laboratory biomarker analysis, recombinant interleukin-12
Phase phase 1/phase 2
Target EGFR
Sponsor National Cancer Institute (NCI)
Start date October 2011
End date December 2016
Trial size 47 participants
Trial identifier NCT01468896, 11010, 2011C0019, 8860, CDR0000715306, N01CM00070, NCI-2011-03631, OSU 11010, P30CA016058, U01CA076576, UM1CA186712

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
cetuximab Chimeric Anti-EGFR Monoclonal Antibody
Given IV
laboratory biomarker analysis
Correlative studies
recombinant interleukin-12 Cytotoxic Lymphocyte Maturation Factor
Given SC

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Induction of systemic plasma levels of interferon-gamma
time frame: Baseline up to day 50
Number of confirmed clinical responses (phase I)
time frame: Up to 6 months
Overall survival (phase II)
time frame: From the date of registration to date of death, assessed up to 1 year
Proportion of patients who are progression-free (phase I)
time frame: 6 months
Time to disease progression (phase II)
time frame: From date of registration to date of progression, assessed up to 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator William Carson
Description 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 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 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).