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
48 subjects were enrolled; 1 additional subject withdrew informed consent before any measurements or treatment. 46 subjects (27 in the 1- to 12-yrs-old group and 19 subjects in the 13- to 18-yrs-old group) were treated; 2 subjects in the 13-18 yrs group were not treated, and are NOT included in Participant Flow or Baseline Characteristics tables.

Reporting Groups

	Description
1- to 12-years-old	No text entered.
13- to 18-years-old	No text entered.

Participant Flow:   Overall Study

	1- to 12-years-old	13- to 18-years-old
STARTED	27	19
COMPLETED	0[1]	0[2]
NOT COMPLETED	27	19
Deterioration without progression	2	0
Disease progression/relapse	20	15
Study Closure	1	0
Study Drug Toxicity	1	3
Withdrawal by Subject	3	1

Reporting Groups

	Description
1- to 12-years-old	No text entered.
13- to 18-years-old	No text entered.

Baseline Measures

	1- to 12-years-old	13- to 18-years-old	Total
Number of Participants   [units: participants]	27	19	46
Age   [units: years] Median ( Full Range )	8.0 ( 1.0 to 12.0 )	16.0 ( 13.0 to 18.0 )	10 ( 1.0 to 18.0 )
Gender   [units: participants]
Female	15	9	24
Male	12	10	22
Race/Ethnicity, Customized   [units: Participants]
Asian	0	2	2
Black or African American	5	2	7
White	21	14	35
Other	1	1	2
Disease diagnosis   [units: Participants]
CNS Primary Tumor	17	9	26
Non-CNS Primary Tumor	10	10	20
Performance Status[1] [units: Participants]
>70-100	19	16	35
≥50-70	8	3	11
<50	0	0	0

1.  Primary:

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan   [ Continuous assessment of safety throughout the entire study period and determination of doe-limiting toxicities during and at the end of Cycle 1. ]

2.  Secondary:

Number of Participants With a Dose-Limiting Toxicity   [ Prior to each 21-day cycle until dose-limiting toxicities ]

3.  Secondary:

Maximum Plasma Concentration (Cmax)   [ up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study ]

4.  Secondary:

Area Under the Curve, Extrapolated to Infinity (AUC[INF])   [ up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study ]

5.  Secondary:

Terminal Half-Life (T-Half)   [ up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study ]

6.  Secondary:

Clearance Corrected for Body Surface Area (CL/BSA)   [ up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study ]

7.  Secondary:

Volume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA)   [ up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study ]

8.  Secondary:

Tumor Response   [ Every other 21-day cycle ]

9.  Secondary:

Human Anti-cetuximab Antibody (HACA) Response   [ Blood was drawn immediately prior to cetuximab infusions, on a 21-day cycle ]

10.  Secondary:

Number of Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs)   [ Weekly throughout the study and every 4 weeks thereafter ]

11.  Secondary:

Grade 3-4 Laboratory Abnormalities - Leukopenia   [ pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment ]

12.  Secondary:

Grade 3-4 Laboratory Abnormalities - Neutropenia   [ pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment ]

13.  Secondary:

Grade 3-4 Laboratory Abnormalities - Thrombocytopenia   [ pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment ]

14.  Secondary:

Grade 3/4 Laboratory Abnormalities - Hypomagnesemia   [ pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment ]