Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    "Opsoclonus-Myoclonus Syndrome" | "Antibodies"
Previous Study | Return to List | Next Study

Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00033293
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : October 3, 2016
Last Update Posted : May 22, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Disseminated Neuroblastoma
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4S Neuroblastoma
Interventions Biological: therapeutic immune globulin
Other: clinical observation
Drug: cyclophosphamide
Drug: prednisone
Procedure: magnetic resonance imaging
Other: laboratory biomarker analysis
Drug: Corticotropin-Releasing Hormone
Enrollment 53
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Chemotherapy, Immunoglobulin Therapy) Arm II (Chemotherapy, Observation)
Hide Arm/Group Description

Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.

Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).

Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.

Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.

Period Title: Overall Study
Started 26 27
Completed 16 9
Not Completed 10 18
Reason Not Completed
Death             0             1
Lack of Efficacy             5             8
Lost to Follow-up             0             1
Physician Decision             3             1
Withdrawal by Subject             1             0
Could not be weaned from steroid therapy             1             1
Treatment refused             0             6
Arm/Group Title Arm I (Chemotherapy, Immunoglobulin Therapy) Arm II (Chemotherapy, Observation) Total
Hide Arm/Group Description

Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.

Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).

Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.

Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.

Total of all reporting groups
Overall Number of Baseline Participants 26 27 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 27 participants 53 participants
<=18 years
26
 100.0%
27
 100.0%
53
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 27 participants 53 participants
1.4  (0.9) 1.2  (0.5) 1.3  (0.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 27 participants 53 participants
Female
18
  69.2%
15
  55.6%
33
  62.3%
Male
8
  30.8%
12
  44.4%
20
  37.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 27 participants 53 participants
Hispanic or Latino
5
  19.2%
7
  25.9%
12
  22.6%
Not Hispanic or Latino
20
  76.9%
20
  74.1%
40
  75.5%
Unknown or Not Reported
1
   3.8%
0
   0.0%
1
   1.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 27 participants 53 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.8%
0
   0.0%
1
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  19.2%
6
  22.2%
11
  20.8%
White
19
  73.1%
17
  63.0%
36
  67.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   3.8%
4
  14.8%
5
   9.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 27 participants 53 participants
26 27 53
1.Primary Outcome
Title Number of Responders
Hide Description A multi-stage design followed by a test of proportions between the treatment arms (chemo vs. chemo + therapeutic immune globulin (IVIG)) will be performed. The first stage of the multi-stage design will also function as an early stopping rule for insufficient activity of chemotherapy in OMA.
Time Frame Changes from baseline to 2 months, 6 months, and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients
Arm/Group Title Arm I (Chemotherapy, Immunoglobulin Therapy) Arm II (Chemotherapy, Observation)
Hide Arm/Group Description:

Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.

Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).

Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.

Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.

Overall Number of Participants Analyzed 26 26
Measure Type: Number
Unit of Measure: participants
21 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Chemotherapy, Immunoglobulin Therapy), Arm II (Chemotherapy, Observation)
Comments The 5 categories of OMA ratings are: stance, gait, arm & hand function, opsoclonus, & mood/behavior. For each category, a patient's response will be based on a comparison of the baseline evaluation to the "best" of 3 time points: 2 months, 6 months & 1 year. If a patient crosses over to the IVIG arm or switches to ACTH at any time, the patient will be considered a non-responder. The proportion of responders from the 2 treatment arms were compared using a chi-squared test.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0044
Comments No adjustments for multiple comparisons.
Method Chi-squared
Comments A two-way test with a null hypothesis of no association, using SAS 9.4.
Method of Estimation Estimation Parameter Chi-squared test statistic
Estimated Value 8.125
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)
Hide Description The "best" score at the two time points will be used in this analysis. For a given patient, this "best" score will be used to calculate the change from baseline. The mean change from baseline for each treatment group will be calculated.
Time Frame Changes from baseline to the better of 6 months or 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who had VABS measures at diagnosis and at least one of 6 months or 1 year.
Arm/Group Title Arm I (Chemotherapy, Immunoglobulin Therapy) Arm II (Chemotherapy, Observation)
Hide Arm/Group Description:
Randomized to chemotherapy, immunoglobulin therapy.
Randomized to chemotherapy, observation
Overall Number of Participants Analyzed 17 11
Mean (Standard Deviation)
Unit of Measure: Change in VABS score
84.53  (115.91) 144.73  (110.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Chemotherapy, Immunoglobulin Therapy), Arm II (Chemotherapy, Observation)
Comments The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0919
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 60.1979
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing
Hide Description The Bayley Scales of infant development mental scale "best" score of two time points will be used in the analysis. For a given patient, this score will be used to calculate the change from baseline.
Time Frame Changes from baseline to the better of 6 months or 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who had Bayley's measures at diagnosis and at least one of 6 months or 1 year.
Arm/Group Title Arm I (Chemotherapy, Immunoglobulin Therapy) Arm II (Chemotherapy, Observation)
Hide Arm/Group Description:
Randomized to chemotherapy, immunoglobulin therapy.
Randomized to chemotherapy, observation
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: Change in Bayley's score
117.5  (35.35) 100.75  (25.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Chemotherapy, Immunoglobulin Therapy), Arm II (Chemotherapy, Observation)
Comments [Not Specified]
Type of Statistical Test Other
Comments The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.
Statistical Test of Hypothesis P-Value 0.2364
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 16.75
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Biology of Neuroblastoma Associated Opsoclonus-myoclonus-ataxia (OMA) Syndrome Specifically by MRI Findings, Anti-neuronal Antibodies, Cerebrospinal Fluid (CSF) Findings and Tumor Biology
Hide Description Descriptive analyses on biologic variables will be performed
Time Frame At diagnosis, 6 months, 1 year, 5 and 10 years after diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
The data is not available at this time. Investigators have not finished analyzing the specimens or reviewing the patient study data required to evaluate this study objective.
Arm/Group Title Arm I (Chemotherapy, Immunoglobulin Therapy) Arm II (Chemotherapy, Observation)
Hide Arm/Group Description:
Randomized to chemotherapy, immunoglobulin therapy.
Randomized to chemotherapy, observation
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Long-term Prognosis for Neurologic Recovery by Neurological Examination
Hide Description A t-test will be performed on the results of each neurologic test, comparing patients who have had disappearance of anti-neural antibodies to patients whose anti-neural antibodies have not disappeared.
Time Frame At diagnosis and yearly for 10 years after diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
The data is not available at this time. Investigators have not finished analyzing the specimens or reviewing the patient study data required to evaluate this study objective.
Arm/Group Title Arm I (Chemotherapy, Immunoglobulin Therapy) Arm II (Chemotherapy, Observation)
Hide Arm/Group Description:
Randomized to chemotherapy, immunoglobulin therapy.
Randomized to chemotherapy, observation
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death
Hide Description EFS rate for neuroblastoma event from time of study enrollment.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible randomized patients.
Arm/Group Title Arm I (Chemotherapy, Immunoglobulin Therapy) Arm II (Chemotherapy, Observation)
Hide Arm/Group Description:
Randomized to chemotherapy, immunoglobulin therapy.
Randomized to chemotherapy, observation
Overall Number of Participants Analyzed 26 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: 3 year EFS
92.3
(81.8 to 100)
96.0
(87.8 to 100)
7.Secondary Outcome
Title Tumor Outcome in Terms of Overall Survival (OS) Rate
Hide Description OS rate from time of study enrollment.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible randomized patients.
Arm/Group Title Arm I (Chemotherapy, Immunoglobulin Therapy) Arm II (Chemotherapy, Observation)
Hide Arm/Group Description:
Randomized to chemotherapy, immunoglobulin therapy.
Randomized to chemotherapy, observation
Overall Number of Participants Analyzed 26 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: 3 year OS
100
(100 to 100)
96.0
(87.8 to 100)
Time Frame [Not Specified]
Adverse Event Reporting Description The SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs), regardless of grade. The other AE field contains all CTCAEs reported on study excluding those that were reported as SAEs, regardless of grade.
 
Arm/Group Title Arm I (Chemotherapy, Immunoglobulin Therapy) Arm II (Chemotherapy, Observation)
Hide Arm/Group Description

Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.

Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH).

Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.

Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.

All-Cause Mortality
Arm I (Chemotherapy, Immunoglobulin Therapy) Arm II (Chemotherapy, Observation)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Chemotherapy, Immunoglobulin Therapy) Arm II (Chemotherapy, Observation)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/26 (3.85%)      1/27 (3.70%)    
Infections and infestations     
53100-Lung infection  0/26 (0.00%)  0 1/27 (3.70%)  1
Investigations     
15000-Aspartate aminotransferase increased  1/26 (3.85%)  1 0/27 (0.00%)  0
1
Term from vocabulary, CTCv4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Chemotherapy, Immunoglobulin Therapy) Arm II (Chemotherapy, Observation)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/26 (50.00%)      18/27 (66.67%)    
Blood and lymphatic system disorders     
13200-Anemia  1/26 (3.85%)  3 4/27 (14.81%)  6
33300-Febrile neutropenia  1/26 (3.85%)  2 1/27 (3.70%)  3
Cardiac disorders     
74200-Sinus bradycardia  0/26 (0.00%)  0 1/27 (3.70%)  1
Endocrine disorders     
11200-Adrenal insufficiency  0/26 (0.00%)  0 1/27 (3.70%)  1
24200-Cushingoid  0/26 (0.00%)  0 2/27 (7.41%)  3
Gastrointestinal disorders     
22100-Colitis  0/26 (0.00%)  0 1/27 (3.70%)  1
25700-Diarrhea  1/26 (3.85%)  1 0/27 (0.00%)  0
31200-Esophagitis  0/26 (0.00%)  0 1/27 (3.70%)  1
36700-Gastrointestinal disorders - Other specify  0/26 (0.00%)  0 1/27 (3.70%)  1
46300-Intra-abdominal hemorrhage(targeted toxicity)  0/26 (0.00%)  0 1/27 (3.70%)  1
55600-Mucositis oral  0/26 (0.00%)  0 1/27 (3.70%)  1
57600-Nausea(targeted toxicity)  1/26 (3.85%)  1 2/27 (7.41%)  5
87900-Vomiting(targeted toxicity)  5/26 (19.23%)  6 5/27 (18.52%)  10
General disorders     
33900-Fever  1/26 (3.85%)  1 1/27 (3.70%)  1
48700-Irritability  0/26 (0.00%)  0 3/27 (11.11%)  4
Infections and infestations     
16800-Bladder infection  2/26 (7.69%)  2 1/27 (3.70%)  1
20500-Catheter related infection  1/26 (3.85%)  1 2/27 (7.41%)  2
29500-Enterocolitis infectious  0/26 (0.00%)  0 1/27 (3.70%)  1
44800-Infections and infestations - Other specify  2/26 (7.69%)  2 7/27 (25.93%)  14
82300-Upper respiratory infection  0/26 (0.00%)  0 1/27 (3.70%)  1
83100-Urinary tract infection  0/26 (0.00%)  0 1/27 (3.70%)  1
Injury, poisoning and procedural complications     
34900-Fracture  0/26 (0.00%)  0 2/27 (7.41%)  2
Investigations     
11600-Alanine aminotransferase increased  2/26 (7.69%)  4 0/27 (0.00%)  0
15000-Aspartate aminotransferase increased  1/26 (3.85%)  1 0/27 (0.00%)  0
53700-Lymphocyte count decreased  0/26 (0.00%)  0 1/27 (3.70%)  1
58300-Neutrophil count decreased  1/26 (3.85%)  4 3/27 (11.11%)  8
65800-Platelet count decreased  0/26 (0.00%)  0 1/27 (3.70%)  3
88200-Weight gain  0/26 (0.00%)  0 1/27 (3.70%)  1
88500-White blood cell decreased  1/26 (3.85%)  4 2/27 (7.41%)  3
Metabolism and nutrition disorders     
13500-Anorexia  1/26 (3.85%)  2 0/27 (0.00%)  0
24700-Dehydration  0/26 (0.00%)  0 2/27 (7.41%)  2
41300-Hypercalcemia  1/26 (3.85%)  1 0/27 (0.00%)  0
41400-Hyperglycemia(targeted toxicity)  1/26 (3.85%)  2 4/27 (14.81%)  6
41600-Hyperkalemia  1/26 (3.85%)  1 0/27 (0.00%)  0
42600-Hypoalbuminemia  1/26 (3.85%)  2 0/27 (0.00%)  0
42700-Hypocalcemia  1/26 (3.85%)  3 1/27 (3.70%)  3
42900-Hypoglycemia  0/26 (0.00%)  0 1/27 (3.70%)  1
43100-Hypokalemia  1/26 (3.85%)  1 2/27 (7.41%)  3
43300-Hyponatremia  0/26 (0.00%)  0 1/27 (3.70%)  1
43500-Hypophosphatemia  0/26 (0.00%)  0 2/27 (7.41%)  3
Nervous system disorders     
15300-Ataxia  1/26 (3.85%)  1 4/27 (14.81%)  6
58700-Nystagmus  2/26 (7.69%)  3 9/27 (33.33%)  14
69300-Pyramidal tract syndrome  0/26 (0.00%)  0 1/27 (3.70%)  1
Psychiatric disorders     
11400-Agitation  4/26 (15.38%)  8 11/27 (40.74%)  25
13700-Anxiety(targeted toxicity)  0/26 (0.00%)  0 1/27 (3.70%)  1
64400-Personality change  1/26 (3.85%)  1 0/27 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
43900-Hypoxia  0/26 (0.00%)  0 1/27 (3.70%)  1
Skin and subcutaneous tissue disorders     
41500-Hyperhidrosis  1/26 (3.85%)  1 0/27 (0.00%)  0
69700-Rash maculo-papular(targeted toxicity)  1/26 (3.85%)  1 0/27 (0.00%)  0
Vascular disorders     
42100-Hypertension  0/26 (0.00%)  0 3/27 (11.11%)  7
1
Term from vocabulary, CTCv4
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Must obtain prior Sponsor approval
Results Point of Contact
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00033293     History of Changes
Other Study ID Numbers: ANBL00P3
NCI-2009-00399 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000069271 ( Other Identifier: Clinical Trials.gov )
COG-ANBL00P3 ( Other Identifier: Children's Oncology Group )
U10CA013539 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: April 9, 2002
First Posted: January 27, 2003
Results First Submitted: January 28, 2016
Results First Posted: October 3, 2016
Last Update Posted: May 22, 2017