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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01468896
First Posted: November 10, 2011
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: July 31, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Head and Neck Squamous Cell Carcinoma
Interventions: Biological: Cetuximab
Other: Laboratory Biomarker Analysis
Biological: Recombinant Interleukin-12

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Arm 1 (Phase I)   Arm II (Phase II)
STARTED   6   17 
COMPLETED   6   17 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1 (Phase 1) 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.
Total Total of all reporting groups

Baseline Measures
   Arm 1 (Phase 1)   Arm II (Phase II)   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   17   23 
Age 
[Units: Years]
Median (Full Range)
 56.5 
 (52 to 64) 
 62 
 (51 to 84) 
 61 
 (51 to 84) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  16.7%      0   0.0%      1   4.3% 
Male      5  83.3%      17 100.0%      22  95.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      6 100.0%      16  94.1%      22  95.7% 
Unknown or Not Reported      0   0.0%      1   5.9%      1   4.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   5.9%      1   4.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1   5.9%      1   4.3% 
White      5  83.3%      14  82.4%      19  82.6% 
More than one race      1  16.7%      0   0.0%      1   4.3% 
Unknown or Not Reported      0   0.0%      1   5.9%      1   4.3% 
Region of Enrollment 
[Units: Participants]
     
United States   6   17   23 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Secondary:   Induction of Systemic Plasma Levels of Interferon-gamma   [ Time Frame: Baseline up to day 50 ]

4.  Secondary:   Number of Confirmed Clinical Responses (Phase I)   [ Time Frame: Up to 6 months ]

5.  Secondary:   Overall Survival (Phase II)   [ Time Frame: From the date of registration to date of death, assessed up to 1 year ]

6.  Secondary:   Proportion of Patients Who Are Progression-free (Phase I)   [ Time Frame: 6 months ]

7.  Secondary:   Time to Disease Progression (Phase II)   [ Time Frame: From date of registration to date of progression, assessed up to 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: William Carson, MD
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-6306
e-mail: William.Carson@osumc.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01468896     History of Changes
Other Study ID Numbers: NCI-2011-03631
NCI-2011-03631 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
11010
2011C0019
CDR0000715306
OSU 11010 ( Other Identifier: Ohio State University Comprehensive Cancer Center )
8860 ( Other Identifier: CTEP )
N01CM00070 ( U.S. NIH Grant/Contract )
P30CA016058 ( U.S. NIH Grant/Contract )
U01CA076576 ( U.S. NIH Grant/Contract )
UM1CA186712 ( U.S. NIH Grant/Contract )
First Submitted: November 8, 2011
First Posted: November 10, 2011
Results First Submitted: July 31, 2017
Results First Posted: August 31, 2017
Last Update Posted: August 31, 2017