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
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 |
---|---|---|
|
Phase 2 |
Study Design
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
- Number of Participants With High-grade Astrocytoma and Diffuse Pontine Tumors Achieving One Year Progression Free Survival. [1 year]
- 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
- Time to Progression [2 years]
- 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.
- Number of Samples Demonstrating EGFR Copy Number Gain [2 years]
Identify gene transcripts for putative cetuximab
- Number of Participant Tumors Analyzed for Potential Association Between Histology (Grade) With Protein and ELISA Measurements of Those Proteins. [2 years]
- 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.
- Event Free Survival [up to 12 months]
- Overall Survival [Up to 43 months]
Eligibility Criteria
Criteria
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.- 09-014
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
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%
|
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%
|
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
|
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%
|
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
|
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%
|
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%
|
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
|
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
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 |
dunkeli@mskcc.org |
- 09-014