Trial Outcomes & Findings for External Beam Radiation Therapy and Cetuximab Followed by Irinotecan and Cetuximab for Children and Young Adults With Newly Diagnosed Diffuse Pontine Tumors and High-Grade Astrocytomas (NCT NCT01012609)
NCT ID: NCT01012609
Last Updated: 2022-03-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
1 year
Results posted on
2022-03-14
Participant Flow
Participant milestones
| Measure |
Pts With High-grade Astrocytoma
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
Pts With Diffuse Pontine Tumor
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
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|---|---|---|
|
Overall Study
STARTED
|
21
|
26
|
|
Overall Study
COMPLETED
|
20
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Pts With High-grade Astrocytoma
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
Pts With Diffuse Pontine Tumor
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
External Beam Radiation Therapy and Cetuximab Followed by Irinotecan and Cetuximab for Children and Young Adults With Newly Diagnosed Diffuse Pontine Tumors and High-Grade Astrocytomas
Baseline characteristics by cohort
| Measure |
Pts With High-grade Astrocytoma
n=21 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
Pts With Diffuse Pontine Tumor
n=26 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
Total
n=47 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
10.7 years
n=5 Participants
|
6.4 years
n=7 Participants
|
8.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Pts With High-grade Astrocytoma
n=20 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
Pts With Diffuse Pontine Tumor
n=25 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
|---|---|---|
|
Number of Participants With High-grade Astrocytoma and Diffuse Pontine Tumors Achieving One Year Progression Free Survival.
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTo determine the safety of cetuximab administered weekly in conjunction with involved field external beam radiation therapy for diffuse pontine tumors and high-grade astrocytomas, toxicities will be assessed via the NCI Common Terminology Criteria for Adverse Events (CTCAE, version 3.0)
Outcome measures
| Measure |
Pts With High-grade Astrocytoma
n=20 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
Pts With Diffuse Pontine Tumor
n=25 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
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|---|---|---|
|
Number of Participants Experiencing Toxicity
|
20 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Pts With High-grade Astrocytoma
n=20 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
Pts With Diffuse Pontine Tumor
n=25 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
|---|---|---|
|
Time to Progression
|
9.02 months
Interval 8.52 to 11.8
|
7.12 months
Interval 6.89 to 12.5
|
SECONDARY outcome
Timeframe: 2 yearsParticipant tumor analysis for potential associations between primary tumor tissue molecular markers and tumor response.
Outcome measures
| Measure |
Pts With High-grade Astrocytoma
n=20 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
Pts With Diffuse Pontine Tumor
n=25 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
|---|---|---|
|
Number of Participants Who Have Undergone Tumor Analysis
Tumor Analyzed
|
18 Participants
|
1 Participants
|
|
Number of Participants Who Have Undergone Tumor Analysis
Tumor Did Not Undergo Analysis
|
2 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Paraffin-embedded tumor sections were obtained from 19 of 23 patients who underwent surgery (18 HGA and one DIPG). Because only 1 DIPG sample was available and based on the number of available samples per arm it was pre-specified to pool data for this Outcome Measure.
Identify gene transcripts for putative cetuximab
Outcome measures
| Measure |
Pts With High-grade Astrocytoma
n=19 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
Pts With Diffuse Pontine Tumor
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
|---|---|---|
|
Number of Samples Demonstrating EGFR Copy Number Gain
With GFR copy number gain
|
18 samples
|
—
|
|
Number of Samples Demonstrating EGFR Copy Number Gain
No GFR copy number gain
|
1 samples
|
—
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Pts With High-grade Astrocytoma
n=20 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
Pts With Diffuse Pontine Tumor
n=25 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
|---|---|---|
|
Number of Participant Tumors Analyzed for Potential Association Between Histology (Grade) With Protein and ELISA Measurements of Those Proteins.
Tumor tissue analysis completed
|
18 Participants
|
1 Participants
|
|
Number of Participant Tumors Analyzed for Potential Association Between Histology (Grade) With Protein and ELISA Measurements of Those Proteins.
Tumor tissue analysis Not Done
|
2 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 2 yearsThe purpose is to investigate whether the rash associated with cetuximab is secondary to an inflammatory pathway initiated and mediated by the action of cetuximab on host cells.
Outcome measures
| Measure |
Pts With High-grade Astrocytoma
n=20 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
Pts With Diffuse Pontine Tumor
n=25 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
|---|---|---|
|
Percentage of Participants With Development of Rash, Either Acneiform and/or Desquamation
|
60 percentage of participants
|
53.3 percentage of participants
|
SECONDARY outcome
Timeframe: up to 12 monthsOutcome measures
| Measure |
Pts With High-grade Astrocytoma
n=20 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
Pts With Diffuse Pontine Tumor
n=25 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
|---|---|---|
|
Event Free Survival
|
8.9 months
Interval 5.8 to 11.8
|
6.9 months
Interval 5.34 to 9.05
|
SECONDARY outcome
Timeframe: Up to 43 monthsOutcome measures
| Measure |
Pts With High-grade Astrocytoma
n=20 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
Pts With Diffuse Pontine Tumor
n=25 Participants
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
|---|---|---|
|
Overall Survival
|
17.4 months
Interval 14.72 to 42.1
|
12.1 months
Interval 9.93 to 18.0
|
Adverse Events
Pts With High-grade Astrocytoma
Serious events: 16 serious events
Other events: 21 other events
Deaths: 16 deaths
Pts With Diffuse Pontine Tumor
Serious events: 17 serious events
Other events: 26 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Pts With High-grade Astrocytoma
n=21 participants at risk
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
Pts With Diffuse Pontine Tumor
n=26 participants at risk
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
|---|---|---|
|
Nervous system disorders
Ataxia (incoordination)
|
0.00%
0/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Nervous system disorders
CNS necrosis/cystic progression
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Gastrointestinal disorders
Colitis, infectious
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
General disorders
Death not assoc w CTCAE term-Disease prog NOS
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
3/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Gastrointestinal disorders
Diarrhea
|
19.0%
4/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Gastrointestinal disorders
Dysphagia (Difficulty swallowing)
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Nervous system disorders
Extrpyrmdl/invlntry mvmnt/rstlssnss
|
0.00%
0/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Nervous system disorders
Hemorrhage, CNS
|
0.00%
0/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Nervous system disorders
Hydrocephalus
|
23.8%
5/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Blood
|
0.00%
0/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Cellulitis(skin)
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Infections and infestations
Inf unknown ANC-Blood
|
0.00%
0/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Infections and infestations
Inf unknown ANC-Pneumonia(lung)
|
0.00%
0/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Infections and infestations
Infection, other
|
14.3%
3/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Intra-operat injury- Brain
|
0.00%
0/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Eye disorders
Keratitis (corneal inflamm/ulceratn)
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Nervous system disorders
Leak, cerebrospinal fluid (CSF)
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Investigations
Lymphopenia
|
0.00%
0/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Psychiatric disorders
Mood alteration - Agitation
|
0.00%
0/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Gastrointestinal disorders
Mucositis (Clin exam)- Oral cavity
|
0.00%
0/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Gastrointestinal disorders
Nausea
|
14.3%
3/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Nervous system disorders
Neurology - Other (specify)
|
4.8%
1/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Nervous system disorders
Neuropathy: cranial - CN II Vision
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Nervous system disorders
Neuropathy: motor
|
9.5%
2/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Nervous system disorders
Nrpthy:cranl-CN IX Mtr-phrynx;snsry-ear,phrynx,tng
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Nervous system disorders
Nrpthy:cranl-CN X Mtr-palate;phrynx,lrynx
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Nervous system disorders
Pain - Head/headache
|
9.5%
2/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
General disorders
Pain - Pain NOS
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Psychiatric disorders
Personality/behavioral
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
9.5%
2/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulm/upp respiratory - Other (spec)
|
0.00%
0/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Renal and urinary disorders
Renal/Genitourinary-Other Specify
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Nervous system disorders
Seizure
|
19.0%
4/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
0.00%
0/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Nervous system disorders
Somnolence/dprssd level of conscious
|
0.00%
0/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Nervous system disorders
Speech impairment
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Renal and urinary disorders
Urinary retention (includ neurogenic bladder)
|
0.00%
0/21 • Up to 43 months
|
3.8%
1/26 • Up to 43 months
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
3/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Investigations
Weight loss
|
4.8%
1/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
Other adverse events
| Measure |
Pts With High-grade Astrocytoma
n=21 participants at risk
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
Pts With Diffuse Pontine Tumor
n=26 participants at risk
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan: External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
|
|---|---|---|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
14.3%
3/21 • Up to 43 months
|
26.9%
7/26 • Up to 43 months
|
|
Immune system disorders
Allerg react/hypersens (incl drug fever)
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Investigations
ALT, SGPT
|
42.9%
9/21 • Up to 43 months
|
19.2%
5/26 • Up to 43 months
|
|
Metabolism and nutrition disorders
Anorexia
|
42.9%
9/21 • Up to 43 months
|
38.5%
10/26 • Up to 43 months
|
|
Investigations
AST, SGOT
|
28.6%
6/21 • Up to 43 months
|
15.4%
4/26 • Up to 43 months
|
|
Nervous system disorders
Ataxia (incoordination)
|
23.8%
5/21 • Up to 43 months
|
42.3%
11/26 • Up to 43 months
|
|
Ear and labyrinth disorders
Auditory/Ear, other
|
0.00%
0/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Investigations
Bicarbonate, serum-low
|
14.3%
3/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Metabolism and nutrition disorders
Calcium, low (hypocalcemia)
|
33.3%
7/21 • Up to 43 months
|
15.4%
4/26 • Up to 43 months
|
|
Gastrointestinal disorders
Constipation
|
14.3%
3/21 • Up to 43 months
|
26.9%
7/26 • Up to 43 months
|
|
Endocrine disorders
Cushingoid appearance
|
9.5%
2/21 • Up to 43 months
|
42.3%
11/26 • Up to 43 months
|
|
General disorders
Death not assoc w CTCAE term-Disease prog NOS
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Metabolism and nutrition disorders
Dehydration
|
23.8%
5/21 • Up to 43 months
|
19.2%
5/26 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin, other
|
9.5%
2/21 • Up to 43 months
|
15.4%
4/26 • Up to 43 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
7/21 • Up to 43 months
|
34.6%
9/26 • Up to 43 months
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
0.00%
0/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Nervous system disorders
Dizziness
|
14.3%
3/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
3/21 • Up to 43 months
|
26.9%
7/26 • Up to 43 months
|
|
Gastrointestinal disorders
Dysphagia (Difficulty swallowing)
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
9.5%
2/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
9.5%
2/21 • Up to 43 months
|
23.1%
6/26 • Up to 43 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
General disorders
Fever (in the absence of neutropenia)
|
14.3%
3/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
19.0%
4/21 • Up to 43 months
|
19.2%
5/26 • Up to 43 months
|
|
Metabolism and nutrition disorders
Glucose, low (hypoglycemia)
|
0.00%
0/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Ear and labyrinth disorders
Hearing:pts w/o BL audiogm & not enroll in mon prg
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
28.6%
6/21 • Up to 43 months
|
19.2%
5/26 • Up to 43 months
|
|
Nervous system disorders
Hydrocephalus
|
33.3%
7/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Renal and urinary disorders
Incontinence, urinary
|
0.00%
0/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Mucosa
|
0.00%
0/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Myositis infection(muscle)
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Otitis externa
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Infections and infestations
Inf unknown ANC-Cellulitis(skin)
|
0.00%
0/21 • Up to 43 months
|
15.4%
4/26 • Up to 43 months
|
|
Infections and infestations
Infection, other
|
38.1%
8/21 • Up to 43 months
|
42.3%
11/26 • Up to 43 months
|
|
Injury, poisoning and procedural complications
Intra-op injury- CN VII (facial) motor-face
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Eye disorders
Keratitis (corneal inflamm/ulceratn)
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Nervous system disorders
Leak, cerebrospinal fluid (CSF)
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Investigations
Leukocytes (total WBC)
|
42.9%
9/21 • Up to 43 months
|
50.0%
13/26 • Up to 43 months
|
|
Investigations
Lymphopenia
|
71.4%
15/21 • Up to 43 months
|
76.9%
20/26 • Up to 43 months
|
|
Metabolism and nutrition disorders
Magnesium, low (hypomagnesemia)
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Nervous system disorders
Memory impairment
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Psychiatric disorders
Mood alteration - Agitation
|
9.5%
2/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
0.00%
0/21 • Up to 43 months
|
15.4%
4/26 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Left-sided
|
9.5%
2/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Right-sided
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Gastrointestinal disorders
Nausea
|
47.6%
10/21 • Up to 43 months
|
26.9%
7/26 • Up to 43 months
|
|
Nervous system disorders
Neurology - Other (specify)
|
28.6%
6/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Nervous system disorders
Neuropathy: motor
|
28.6%
6/21 • Up to 43 months
|
50.0%
13/26 • Up to 43 months
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
23.8%
5/21 • Up to 43 months
|
42.3%
11/26 • Up to 43 months
|
|
Nervous system disorders
Nrpthy:cranl-CN III Pupl,upp eyeld, extrclr mvmnts
|
0.00%
0/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Nervous system disorders
Nrpthy:cranl-CN IV Dwnwrd,inwrd eye mvmnt
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Nervous system disorders
Nrpthy:cranl-CN IX Mtr-phrynx;snsry-ear,phrynx,tng
|
0.00%
0/21 • Up to 43 months
|
15.4%
4/26 • Up to 43 months
|
|
Nervous system disorders
Nrpthy:cranl-CN VI Ltrl eye dviatn
|
0.00%
0/21 • Up to 43 months
|
38.5%
10/26 • Up to 43 months
|
|
Nervous system disorders
Nrpthy:cranl-CN VII Mtr-face;snsry-taste
|
14.3%
3/21 • Up to 43 months
|
19.2%
5/26 • Up to 43 months
|
|
Nervous system disorders
Nrpthy:cranl-CN VIII Hearing,balance
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Nervous system disorders
Nrpthy:cranl-CN X Mtr-palate;phrynx,lrynx
|
0.00%
0/21 • Up to 43 months
|
23.1%
6/26 • Up to 43 months
|
|
Nervous system disorders
Nrpthy:cranl-CN XI Mtr-strnmstd,trpzius
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Nervous system disorders
Nrpthy:cranl-CN XII Motor-tongue
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Metabolism and nutrition disorders
Obesity
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Eye disorders
Ocular surface disease
|
0.00%
0/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Ear and labyrinth disorders
Otitis, external ear (non-infect)
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
14.3%
3/21 • Up to 43 months
|
23.1%
6/26 • Up to 43 months
|
|
Nervous system disorders
Pain - Head/headache
|
47.6%
10/21 • Up to 43 months
|
30.8%
8/26 • Up to 43 months
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
23.8%
5/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Investigations
Platelets
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
0.00%
0/21 • Up to 43 months
|
38.5%
10/26 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulm/upp respiratory - Other (spec)
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Nervous system disorders
Pyramidal tract dysfunction
|
9.5%
2/21 • Up to 43 months
|
19.2%
5/26 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
33.3%
7/21 • Up to 43 months
|
34.6%
9/26 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
33.3%
7/21 • Up to 43 months
|
26.9%
7/26 • Up to 43 months
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
14.3%
3/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Nervous system disorders
Seizure
|
28.6%
6/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Metabolism and nutrition disorders
Sodium, high (hypernatremia)
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
0.00%
0/21 • Up to 43 months
|
15.4%
4/26 • Up to 43 months
|
|
Nervous system disorders
Somnolence/dprssd level of conscious
|
9.5%
2/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Nervous system disorders
Speech impairment
|
9.5%
2/21 • Up to 43 months
|
23.1%
6/26 • Up to 43 months
|
|
Cardiac disorders
Supraventricular arrhythmia NOS
|
9.5%
2/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Ear and labyrinth disorders
Tinnitus
|
9.5%
2/21 • Up to 43 months
|
0.00%
0/26 • Up to 43 months
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/21 • Up to 43 months
|
7.7%
2/26 • Up to 43 months
|
|
Nervous system disorders
Voice changes/dysarthria
|
0.00%
0/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Gastrointestinal disorders
Vomiting
|
61.9%
13/21 • Up to 43 months
|
46.2%
12/26 • Up to 43 months
|
|
Investigations
Weight gain
|
23.8%
5/21 • Up to 43 months
|
11.5%
3/26 • Up to 43 months
|
|
Investigations
Weight loss
|
19.0%
4/21 • Up to 43 months
|
23.1%
6/26 • Up to 43 months
|
Additional Information
Dr. Ira Dunkel, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-2153
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place