Trial Outcomes & Findings for 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 (NCT NCT01468896)

NCT ID: NCT01468896

Last Updated: 2025-07-04

Results Overview

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

23 participants

Primary outcome timeframe

14 days

Results posted on

2025-07-04

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 (Phase I) Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.	Arm II (Phase II) Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
Overall Study STARTED	6	17
Overall Study COMPLETED	6	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 (Phase 1) n=6 Participants Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.	Arm II (Phase II) n=17 Participants Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.	Total n=23 Participants Total of all reporting groups
Age, Continuous	56.5 years n=5 Participants	62 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	17 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	16 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants	17 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Outcome measures

Outcome measures
Measure	Arm 1 (Phase I) n=6 Participants Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.	Arm II (Phase II) n=17 Participants Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
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)	2 Dose limiting toxicities	0 Dose limiting toxicities

PRIMARY outcome

Timeframe: 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. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Arm 1 (Phase I) n=17 Participants Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.	Arm II (Phase II) Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
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)	0 proportion of patients	—

SECONDARY outcome

Timeframe: Baseline up to day 50

Population: Unable to compare the plasma levels of interferon-gamma between those with versus without an objective response to therapy due to no objective response seen for Phase I or Phase II patients.

Explores graphically how changes in this marker differ between those with versus without an objective response to therapy as well as other potential factors.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months

Summarized by simple descriptive summary statistics. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Arm 1 (Phase I) n=6 Participants Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.	Arm II (Phase II) Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
Number of Confirmed Clinical Responses (Phase I)	0 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm 1 (Phase I) Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.	Arm II (Phase II) n=17 Participants Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
Overall Survival (Phase II)	—	10.6 months Interval 5.3 to 12.7

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Arm 1 (Phase I) n=6 Participants Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.	Arm II (Phase II) Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
Proportion of Patients Who Are Progression-free (Phase I)	.17 proportion of patients	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm 1 (Phase I) Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.	Arm II (Phase II) n=17 Participants Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
Time to Disease Progression (Phase II)	—	4.6 months Interval 1.8 to 13.3

Adverse Events

Arm 1 (Phase I)

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm II (Phase II)

Serious events: 9 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 (Phase I) n=6 participants at risk Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 (Dose Escalation) on days 2 and 5 of the 2 week cycle, beginning with cycle 2.	Arm II (Phase II) n=17 participants at risk Cetuximab 500 mg/m2 i.v. on day 1 of the two week cycle followed by subcutaneous IL-12 at the MTD on days 2 and 5 of the 2 week cycle beginning with cycle 2. No IL-12 is given in the first cycle. IL-12 dosing will begin in cycle 2. The IL-12 dose is 0.3 mcg/kg.
General disorders General Disorders and administration site conditions	16.7% 1/6 • Number of events 1 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/17 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Injury, poisoning and procedural complications Arterial Injury	16.7% 1/6 • Number of events 1 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/17 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Alkaline phosphatase increased	16.7% 1/6 • Number of events 1 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/17 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Lymphocyte count decreased	16.7% 1/6 • Number of events 1 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/17 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hyponatremia	16.7% 1/6 • Number of events 1 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	0.00% 0/17 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Cardiac disorders Atrial fibrillation	0.00% 0/6 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	5.9% 1/17 • Number of events 1 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Cardiac disorders Supraventricular tachycardia	0.00% 0/6 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	5.9% 1/17 • Number of events 1 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Dysphagia	0.00% 0/6 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	5.9% 1/17 • Number of events 1 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Lung infection	0.00% 0/6 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	5.9% 1/17 • Number of events 1 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	5.9% 1/17 • Number of events 1 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/6 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	5.9% 1/17 • Number of events 1 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm benign, malignant and unspecified	0.00% 0/6 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	5.9% 1/17 • Number of events 1 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/6 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	5.9% 1/17 • Number of events 1 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/6 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.	5.9% 1/17 • Number of events 1 Toxicities were graded using the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Other adverse events

Additional Information

William Carson, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-6306

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60