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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT01012609
Collaborator
Children's Healthcare of Atlanta (Other), Dana-Farber Cancer Institute (Other), M.D. Anderson Cancer Center (Other), Phoenix Children's Hospital (Other), Alberta Children's Hospital (Other), University of Colorado, Denver (Other), Seattle Children's Hospital (Other), Johns Hopkins University (Other), Children's Mercy Hospital Kansas City (Other), University of Florida (Other)
47
12
2
98.5
3.9
0

Study Details

Study Description

Brief Summary

Standard treatment for patients with diffuse pontine tumors is radiation therapy, but less than 10% of patients are cured. Adding standard chemotherapy has not improved the cure rate.

Standard treatment for high-grade astrocytomas is surgery and radiation. The surgeon removes as much of the tumor as she or he can. Radiation after that tries to kill any cancer cells that are left. Some patients also get chemotherapy. These are anti-cancer drugs. They can be given during or after radiation. Current standard treatments do not cure many patients.

In this study the doctors are adding a new medication called cetuximab to the treatment and will also use a chemotherapy medication (irinotecan) that has been promising for patients treated for recurrent disease.

Condition or Disease Intervention/Treatment Phase
  • Other: cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of 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 (POE08-01)
Actual Study Start Date :
Oct 30, 2009
Actual Primary Completion Date :
Jan 15, 2018
Actual Study Completion Date :
Jan 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: 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.

Experimental: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With High-grade Astrocytoma and Diffuse Pontine Tumors Achieving One Year Progression Free Survival. [1 year]

  2. Number of Participants Experiencing Toxicity [2 years]

    To 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)

Secondary Outcome Measures

  1. Time to Progression [2 years]

  2. Number of Participants Who Have Undergone Tumor Analysis [2 years]

    Participant tumor analysis for potential associations between primary tumor tissue molecular markers and tumor response.

  3. Number of Samples Demonstrating EGFR Copy Number Gain [2 years]

    Identify gene transcripts for putative cetuximab

  4. Number of Participant Tumors Analyzed for Potential Association Between Histology (Grade) With Protein and ELISA Measurements of Those Proteins. [2 years]

  5. Percentage of Participants With Development of Rash, Either Acneiform and/or Desquamation [2 years]

    The 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.

  6. Event Free Survival [up to 12 months]

  7. Overall Survival [Up to 43 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients must have either (1) histologic proof of a high-grade astrocytoma reviewed by a POETIC institutional pathologist or (2) a radiological diagnosis via MRI scan of a typical diffuse pontine tumor made by a POETIC institutional neuroradiologist. Patients with a radiological diagnosis via MRI scan of a typical diffuse pontine tumor will be enrolled on the diffuse pontine tumor arm of the study regardless of histology in cases that are biopsied. Note: For collaborating non-POETIC institutions, the reviews may be done by an institutional pathologist/neuroradiologist.

  • Patients must begin study prescribed therapy within 42 days of neurosurgical resection or biopsy of the tumor (high-grade astrocytoma patients) or radiological diagnosis (diffuse pontine tumor patients).

  • Age ≥ 3-years and < 22-years-old.

  • Brain MRI (and any other studies done according to clinical indications) must not show any definitive evidence of leptomeningeal or extra-neural metastases.

  • ANC ≥ 1000/μL and platelet count ≥ 100,000/μL

  • Patients must have adequate organ function as defined by:

  • Hepatic: total bilirubin < 1.5 mg/dl, AST ≤ 2.5 x the upper limit of normal.

  • Renal: serum creatinine ≤ 1.5 x the upper limit of normal for age, or calculated creatinine clearance or nuclear GFR ≥ 70 ml/min/1.73 m2.

  • The patient, or for minors, a parent or legal guardian, must give informed written consent indicating they are aware of the investigational nature of this study.

Exclusion Criteria:
  • Evidence of leptomeningeal or extra-neural metastatic disease.

  • Prior radiation therapy or chemotherapy

  • Pregnancy, mothers unwilling to refrain from breast-feeding, and sexually mature patients unwilling to practice an effective form of birth control.

  • Other significant concomitant medical illnesses that would compromise the patient's ability to receive all prescribed study therapy.

  • Prior therapy which specifically and directly targets the EGFR pathway.

  • Prior severe infusion reaction to a monoclonal antibody.

  • Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.

  • Patients with known Gilbert's Syndrome.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Phoenix Children'S Hospital Phoenix Arizona United States 85016
2 University of Colorado Health Sciences Center Denver Colorado United States
3 University of Florida Gainesville Florida United States
4 MD Anderson Cancer Center Orlando at Arnold Palmer Hospital for Children Orlando Florida United States 32806
5 Children's Healthcare of Atlanta at Egleston Atlanta Georgia United States 30322
6 John Hopkins Medical Center Baltimore Maryland United States 21287
7 Dana Farber Cancer Institute Boston Massachusetts United States 02115
8 Children's Mercy Hospital & Clinics Kansas City Missouri United States 64108
9 Memorial Sloan-Kettering Cancer Center New York New York United States 10065
10 Md Anderson Cancer Center Houston Texas United States 77030
11 Seattle Children'S Hospital Seattle Washington United States
12 Alberta Children'S Hospital Calgary Alberta Canada T2N 1N4

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center
  • Children's Healthcare of Atlanta
  • Dana-Farber Cancer Institute
  • M.D. Anderson Cancer Center
  • Phoenix Children's Hospital
  • Alberta Children's Hospital
  • University of Colorado, Denver
  • Seattle Children's Hospital
  • Johns Hopkins University
  • Children's Mercy Hospital Kansas City
  • University of Florida

Investigators

  • Principal Investigator: Ira Dunkel, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01012609
Other Study ID Numbers:
  • 09-014
First Posted:
Nov 13, 2009
Last Update Posted:
Mar 14, 2022
Last Verified:
Mar 1, 2022

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Pts With High-grade Astrocytoma Pts With Diffuse Pontine Tumor
Arm/Group Description 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. 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.
Period Title: Overall Study
STARTED 21 26
COMPLETED 20 25
NOT COMPLETED 1 1

Baseline Characteristics

Arm/Group Title Pts With High-grade Astrocytoma Pts With Diffuse Pontine Tumor Total
Arm/Group Description 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. 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 of all reporting groups
Overall Participants 21 26 47
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]
10.7
6.4
8.3
Sex: Female, Male (Count of Participants)
Female
8
38.1%
16
61.5%
24
51.1%
Male
13
61.9%
10
38.5%
23
48.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
6
28.6%
6
23.1%
12
25.5%
Not Hispanic or Latino
15
71.4%
20
76.9%
35
74.5%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
1
4.8%
1
3.8%
2
4.3%
Asian
0
0%
1
3.8%
1
2.1%
Native Hawaiian or Other Pacific Islander
1
4.8%
0
0%
1
2.1%
Black or African American
2
9.5%
4
15.4%
6
12.8%
White
16
76.2%
19
73.1%
35
74.5%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
1
4.8%
1
3.8%
2
4.3%
Region of Enrollment (Count of Participants)
United States
21
100%
26
100%
47
100%

Outcome Measures

1. Primary Outcome
Title Number of Participants With High-grade Astrocytoma and Diffuse Pontine Tumors Achieving One Year Progression Free Survival.
Description
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Pts With High-grade Astrocytoma Pts With Diffuse Pontine Tumor
Arm/Group Description 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. 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.
Measure Participants 20 25
Count of Participants [Participants]
5
23.8%
6
23.1%
2. Primary Outcome
Title Number of Participants Experiencing Toxicity
Description To 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)
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Pts With High-grade Astrocytoma Pts With Diffuse Pontine Tumor
Arm/Group Description 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. 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.
Measure Participants 20 25
Count of Participants [Participants]
20
95.2%
25
96.2%
3. Secondary Outcome
Title Time to Progression
Description
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Pts With High-grade Astrocytoma Pts With Diffuse Pontine Tumor
Arm/Group Description 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. 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.
Measure Participants 20 25
Median (95% Confidence Interval) [months]
9.02
7.12
4. Secondary Outcome
Title Number of Participants Who Have Undergone Tumor Analysis
Description Participant tumor analysis for potential associations between primary tumor tissue molecular markers and tumor response.
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Pts With High-grade Astrocytoma Pts With Diffuse Pontine Tumor
Arm/Group Description 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. 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.
Measure Participants 20 25
Tumor Analyzed
18
85.7%
1
3.8%
Tumor Did Not Undergo Analysis
2
9.5%
24
92.3%
5. Secondary Outcome
Title Number of Samples Demonstrating EGFR Copy Number Gain
Description Identify gene transcripts for putative cetuximab
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title HGA and DIPG Tumors Analyzed
Arm/Group Description Paraffin-embedded tumor sections were obtained from 19 of 23 patients who underwent surgery (18 HGA and one DIPG tumors). Found tumor markers are reported as one group in the publication.
Measure Participants 19
With GFR copy number gain
18
No GFR copy number gain
1
6. Secondary Outcome
Title Number of Participant Tumors Analyzed for Potential Association Between Histology (Grade) With Protein and ELISA Measurements of Those Proteins.
Description
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Pts With High-grade Astrocytoma Pts With Diffuse Pontine Tumor
Arm/Group Description 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. 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.
Measure Participants 20 25
Tumor tissue analysis completed
18
85.7%
1
3.8%
Tumor tissue analysis Not Done
2
9.5%
24
92.3%
7. Secondary Outcome
Title Percentage of Participants With Development of Rash, Either Acneiform and/or Desquamation
Description The 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.
Time Frame 2 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Pts With High-grade Astrocytoma Pts With Diffuse Pontine Tumor
Arm/Group Description 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. 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.
Measure Participants 20 25
Number [percentage of participants]
60
285.7%
53.3
205%
8. Secondary Outcome
Title Event Free Survival
Description
Time Frame up to 12 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Pts With High-grade Astrocytoma Pts With Diffuse Pontine Tumor
Arm/Group Description 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. 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.
Measure Participants 20 25
Median (95% Confidence Interval) [months]
8.9
6.9
9. Secondary Outcome
Title Overall Survival
Description
Time Frame Up to 43 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Pts With High-grade Astrocytoma Pts With Diffuse Pontine Tumor
Arm/Group Description 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. 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.
Measure Participants 20 25
Median (95% Confidence Interval) [months]
17.4
12.1

Adverse Events

Time Frame Up to 43 months
Adverse Event Reporting Description
Arm/Group Title Pts With High-grade Astrocytoma Pts With Diffuse Pontine Tumor
Arm/Group Description 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. 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.
All Cause Mortality
Pts With High-grade Astrocytoma Pts With Diffuse Pontine Tumor
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 16/21 (76.2%) 24/26 (92.3%)
Serious Adverse Events
Pts With High-grade Astrocytoma Pts With Diffuse Pontine Tumor
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 16/21 (76.2%) 17/26 (65.4%)
Eye disorders
Keratitis (corneal inflamm/ulceratn) 0/21 (0%) 2/26 (7.7%)
Gastrointestinal disorders
Colitis, infectious 1/21 (4.8%) 0/26 (0%)
Constipation 2/21 (9.5%) 0/26 (0%)
Diarrhea 4/21 (19%) 0/26 (0%)
Dysphagia (Difficulty swallowing) 1/21 (4.8%) 0/26 (0%)
Mucositis (Clin exam)- Oral cavity 0/21 (0%) 1/26 (3.8%)
Nausea 3/21 (14.3%) 1/26 (3.8%)
Pain - Abdomen NOS 2/21 (9.5%) 0/26 (0%)
Vomiting 3/21 (14.3%) 2/26 (7.7%)
General disorders
Death not assoc w CTCAE term-Disease prog NOS 0/21 (0%) 2/26 (7.7%)
Pain - Pain NOS 1/21 (4.8%) 0/26 (0%)
Infections and infestations
Inf norm ANC/gr1/2 neut-Blood 0/21 (0%) 1/26 (3.8%)
Inf norm ANC/gr1/2 neut-Cellulitis(skin) 1/21 (4.8%) 0/26 (0%)
Inf unknown ANC-Blood 0/21 (0%) 1/26 (3.8%)
Inf unknown ANC-Pneumonia(lung) 0/21 (0%) 1/26 (3.8%)
Infection, other 3/21 (14.3%) 3/26 (11.5%)
Injury, poisoning and procedural complications
Intra-operat injury- Brain 0/21 (0%) 1/26 (3.8%)
Investigations
Lymphopenia 0/21 (0%) 3/26 (11.5%)
Weight loss 1/21 (4.8%) 0/26 (0%)
Metabolism and nutrition disorders
Dehydration 3/21 (14.3%) 1/26 (3.8%)
Potassium, low (hypokalemia) 2/21 (9.5%) 3/26 (11.5%)
Sodium, low (hyponatremia) 0/21 (0%) 1/26 (3.8%)
Nervous system disorders
Ataxia (incoordination) 0/21 (0%) 1/26 (3.8%)
CNS necrosis/cystic progression 1/21 (4.8%) 0/26 (0%)
Encephalopathy 0/21 (0%) 1/26 (3.8%)
Extrpyrmdl/invlntry mvmnt/rstlssnss 0/21 (0%) 1/26 (3.8%)
Hemorrhage, CNS 0/21 (0%) 1/26 (3.8%)
Hydrocephalus 5/21 (23.8%) 2/26 (7.7%)
Leak, cerebrospinal fluid (CSF) 1/21 (4.8%) 0/26 (0%)
Neurology - Other (specify) 1/21 (4.8%) 1/26 (3.8%)
Neuropathy: cranial - CN II Vision 1/21 (4.8%) 0/26 (0%)
Neuropathy: motor 2/21 (9.5%) 2/26 (7.7%)
Nrpthy:cranl-CN IX Mtr-phrynx;snsry-ear,phrynx,tng 1/21 (4.8%) 0/26 (0%)
Nrpthy:cranl-CN X Mtr-palate;phrynx,lrynx 1/21 (4.8%) 0/26 (0%)
Pain - Head/headache 2/21 (9.5%) 1/26 (3.8%)
Seizure 4/21 (19%) 2/26 (7.7%)
Somnolence/dprssd level of conscious 0/21 (0%) 1/26 (3.8%)
Speech impairment 1/21 (4.8%) 0/26 (0%)
Psychiatric disorders
Mood alteration - Agitation 0/21 (0%) 1/26 (3.8%)
Personality/behavioral 1/21 (4.8%) 0/26 (0%)
Renal and urinary disorders
Renal/Genitourinary-Other Specify 1/21 (4.8%) 0/26 (0%)
Urinary retention (includ neurogenic bladder) 0/21 (0%) 1/26 (3.8%)
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath) 0/21 (0%) 1/26 (3.8%)
Hypoxia 1/21 (4.8%) 0/26 (0%)
Pulm/upp respiratory - Other (spec) 0/21 (0%) 1/26 (3.8%)
Skin and subcutaneous tissue disorders
Rash/desquamation 1/21 (4.8%) 0/26 (0%)
Vascular disorders
Hypotension 1/21 (4.8%) 1/26 (3.8%)
Thrombosis/thrombus/embolism 1/21 (4.8%) 0/26 (0%)
Other (Not Including Serious) Adverse Events
Pts With High-grade Astrocytoma Pts With Diffuse Pontine Tumor
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 21/21 (100%) 26/26 (100%)
Blood and lymphatic system disorders
Febrile neutropenia 2/21 (9.5%) 0/26 (0%)
Hemoglobin 6/21 (28.6%) 5/26 (19.2%)
Cardiac disorders
Sinus tachycardia 0/21 (0%) 2/26 (7.7%)
Supraventricular arrhythmia NOS 2/21 (9.5%) 2/26 (7.7%)
Ear and labyrinth disorders
Auditory/Ear, other 0/21 (0%) 3/26 (11.5%)
Hearing:pts w/o BL audiogm & not enroll in mon prg 0/21 (0%) 2/26 (7.7%)
Otitis, external ear (non-infect) 0/21 (0%) 2/26 (7.7%)
Tinnitus 2/21 (9.5%) 0/26 (0%)
Endocrine disorders
Cushingoid appearance 2/21 (9.5%) 11/26 (42.3%)
Eye disorders
Keratitis (corneal inflamm/ulceratn) 0/21 (0%) 2/26 (7.7%)
Ocular surface disease 0/21 (0%) 3/26 (11.5%)
Ophthalmoplegia/diplopia (double vision) 2/21 (9.5%) 0/26 (0%)
Vision-blurred vision 0/21 (0%) 2/26 (7.7%)
Gastrointestinal disorders
Constipation 3/21 (14.3%) 7/26 (26.9%)
Diarrhea 7/21 (33.3%) 9/26 (34.6%)
Distension/bloating, abdominal 0/21 (0%) 3/26 (11.5%)
Dysphagia (Difficulty swallowing) 0/21 (0%) 2/26 (7.7%)
Nausea 10/21 (47.6%) 7/26 (26.9%)
Pain - Abdomen NOS 3/21 (14.3%) 6/26 (23.1%)
Vomiting 13/21 (61.9%) 12/26 (46.2%)
General disorders
Death not assoc w CTCAE term-Disease prog NOS 0/21 (0%) 2/26 (7.7%)
Fatigue (asthenia, lethargy, malaise) 2/21 (9.5%) 6/26 (23.1%)
Fever (in the absence of neutropenia) 3/21 (14.3%) 3/26 (11.5%)
Immune system disorders
Allerg react/hypersens (incl drug fever) 2/21 (9.5%) 0/26 (0%)
Infections and infestations
Inf norm ANC/gr1/2 neut-Mucosa 0/21 (0%) 3/26 (11.5%)
Inf norm ANC/gr1/2 neut-Myositis infection(muscle) 0/21 (0%) 2/26 (7.7%)
Inf norm ANC/gr1/2 neut-Otitis externa 2/21 (9.5%) 0/26 (0%)
Inf unknown ANC-Cellulitis(skin) 0/21 (0%) 4/26 (15.4%)
Infection, other 8/21 (38.1%) 11/26 (42.3%)
Injury, poisoning and procedural complications
Intra-op injury- CN VII (facial) motor-face 0/21 (0%) 2/26 (7.7%)
Investigations
ALT, SGPT 9/21 (42.9%) 5/26 (19.2%)
AST, SGOT 6/21 (28.6%) 4/26 (15.4%)
Bicarbonate, serum-low 3/21 (14.3%) 0/26 (0%)
Leukocytes (total WBC) 9/21 (42.9%) 13/26 (50%)
Lymphopenia 15/21 (71.4%) 20/26 (76.9%)
Neutrophils/granulocytes (ANC/AGC) 5/21 (23.8%) 11/26 (42.3%)
Platelets 2/21 (9.5%) 0/26 (0%)
Weight gain 5/21 (23.8%) 3/26 (11.5%)
Weight loss 4/21 (19%) 6/26 (23.1%)
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia) 3/21 (14.3%) 7/26 (26.9%)
Anorexia 9/21 (42.9%) 10/26 (38.5%)
Calcium, low (hypocalcemia) 7/21 (33.3%) 4/26 (15.4%)
Dehydration 5/21 (23.8%) 5/26 (19.2%)
Glucose, high (hyperglycemia) 4/21 (19%) 5/26 (19.2%)
Glucose, low (hypoglycemia) 0/21 (0%) 3/26 (11.5%)
Magnesium, low (hypomagnesemia) 2/21 (9.5%) 0/26 (0%)
Obesity 2/21 (9.5%) 0/26 (0%)
Phosphate, low (hypophosphatemia) 5/21 (23.8%) 0/26 (0%)
Potassium, low (hypokalemia) 10/21 (47.6%) 0/26 (0%)
Potassium, low (hypokalemia) 0/21 (0%) 10/26 (38.5%)
Sodium, high (hypernatremia) 2/21 (9.5%) 0/26 (0%)
Sodium, low (hyponatremia) 0/21 (0%) 4/26 (15.4%)
Musculoskeletal and connective tissue disorders
Muscle weakness - Left-sided 2/21 (9.5%) 2/26 (7.7%)
Muscle weakness - Right-sided 2/21 (9.5%) 0/26 (0%)
Nervous system disorders
Ataxia (incoordination) 5/21 (23.8%) 11/26 (42.3%)
Dizziness 3/21 (14.3%) 2/26 (7.7%)
Hydrocephalus 7/21 (33.3%) 3/26 (11.5%)
Leak, cerebrospinal fluid (CSF) 2/21 (9.5%) 0/26 (0%)
Memory impairment 2/21 (9.5%) 0/26 (0%)
Neurology - Other (specify) 6/21 (28.6%) 2/26 (7.7%)
Neuropathy: motor 6/21 (28.6%) 13/26 (50%)
Nrpthy:cranl-CN III Pupl,upp eyeld, extrclr mvmnts 0/21 (0%) 3/26 (11.5%)
Nrpthy:cranl-CN IV Dwnwrd,inwrd eye mvmnt 0/21 (0%) 2/26 (7.7%)
Nrpthy:cranl-CN IX Mtr-phrynx;snsry-ear,phrynx,tng 0/21 (0%) 4/26 (15.4%)
Nrpthy:cranl-CN VI Ltrl eye dviatn 0/21 (0%) 10/26 (38.5%)
Nrpthy:cranl-CN VII Mtr-face;snsry-taste 3/21 (14.3%) 5/26 (19.2%)
Nrpthy:cranl-CN VIII Hearing,balance 0/21 (0%) 2/26 (7.7%)
Nrpthy:cranl-CN X Mtr-palate;phrynx,lrynx 0/21 (0%) 6/26 (23.1%)
Nrpthy:cranl-CN XI Mtr-strnmstd,trpzius 2/21 (9.5%) 0/26 (0%)
Nrpthy:cranl-CN XII Motor-tongue 0/21 (0%) 2/26 (7.7%)
Pain - Head/headache 10/21 (47.6%) 8/26 (30.8%)
Pyramidal tract dysfunction 2/21 (9.5%) 5/26 (19.2%)
Seizure 6/21 (28.6%) 3/26 (11.5%)
Somnolence/dprssd level of conscious 2/21 (9.5%) 3/26 (11.5%)
Speech impairment 2/21 (9.5%) 6/26 (23.1%)
Voice changes/dysarthria 0/21 (0%) 3/26 (11.5%)
Psychiatric disorders
Mood alteration - Agitation 2/21 (9.5%) 3/26 (11.5%)
Mood alteration - Anxiety 0/21 (0%) 4/26 (15.4%)
Renal and urinary disorders
Incontinence, urinary 0/21 (0%) 3/26 (11.5%)
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath) 2/21 (9.5%) 2/26 (7.7%)
Hypoxia 0/21 (0%) 2/26 (7.7%)
Pulm/upp respiratory - Other (spec) 0/21 (0%) 2/26 (7.7%)
Skin and subcutaneous tissue disorders
Dermatology/Skin, other 2/21 (9.5%) 4/26 (15.4%)
Dry skin 3/21 (14.3%) 7/26 (26.9%)
Pruritus/itching 2/21 (9.5%) 0/26 (0%)
Rash/desquamation 7/21 (33.3%) 9/26 (34.6%)
Rash: acne/acneiform 7/21 (33.3%) 7/26 (26.9%)
Rash: erythema multiforme 3/21 (14.3%) 0/26 (0%)
Vascular disorders
Hypotension 0/21 (0%) 2/26 (7.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT 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.

Results Point of Contact

Name/Title Dr. Ira Dunkel, MD
Organization Memorial Sloan Kettering Cancer Center
Phone 212-639-2153
Email dunkeli@mskcc.org
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01012609
Other Study ID Numbers:
  • 09-014
First Posted:
Nov 13, 2009
Last Update Posted:
Mar 14, 2022
Last Verified:
Mar 1, 2022