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Trial record 40 of 163 for:    ISOTRETINOIN

Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients 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: NCT01041638
Recruitment Status : Completed
First Posted : January 1, 2010
Results First Posted : February 19, 2015
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Stage 4S Neuroblastoma
Interventions Biological: Aldesleukin
Other: Diagnostic Laboratory Biomarker Analysis
Biological: Dinutuximab
Drug: Isotretinoin
Biological: Sargramostim
Enrollment 105
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin
Hide Arm/Group Description Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 105
Completed 78
Not Completed 27
Reason Not Completed
Adverse Event             4
Death             1
Lack of Efficacy             7
Physician Decision             4
Withdrawal by Subject             11
Arm/Group Title Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin
Hide Arm/Group Description Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants
4.1  (4.0)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
<=18 years
103
  98.1%
Between 18 and 65 years
2
   1.9%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Female
46
  43.8%
Male
59
  56.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
American Indian or Alaska Native
1
   1.0%
Asian
2
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
10
   9.5%
White
82
  78.1%
More than one race
0
   0.0%
Unknown or Not Reported
10
   9.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Hispanic or Latino
9
   8.6%
Not Hispanic or Latino
87
  82.9%
Unknown or Not Reported
9
   8.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 105 participants
105
1.Primary Outcome
Title Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever).
Hide Description Designed to collect comprehensive safety/toxicity data, as well as additional efficacy data for the immunotherapy. To address the primary objective, descriptive analyses summarizing the number and type of AEs will be performed. The percentage of patients reporting each unacceptable (Grade 3 or higher) CTC toxicity code, tabulated by course, are reported.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
There was one patient that did not receive treatment, represented on the baseline form as "withdrawal by patient", not included in outcome measure tabulation.
Arm/Group Title Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin
Hide Arm/Group Description:
Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 104
Measure Type: Number
Unit of Measure: percentage of participants
Abdominal pain (10300), course 1 17.3077
Abdominal pain (10300), course 2 5.0000
Abdominal pain (10300), course 3 6.1224
Abdominal pain (10300), course 4 4.4444
Abdominal pain (10300), course 5 5.6818
Abdominal pain (10300), course 6 0.00000
Allergic reaction (12000), Course 1 1.92308
Allergic reaction (12000), Course 2 5.00000
Allergic reaction (12000), Course 3 3.06122
Allergic reaction (12000), Course 4 2.22222
Allergic reaction (12000), Course 5 1.13636
Allergic reaction (12000), Course 6 0.00000
Anal pain (12800), Course 1 0.00000
Anal pain (12800), Course 2 1.00000
Anal pain (12800), Course 3 0.00000
Anal pain (12800), Course 4 0.00000
Anal pain (12800), Course 5 0.00000
Anal pain (12800), Course 6 0.00000
Anaphylaxis (13100), Course 1 0.96154
Anaphylaxis (13100), Course 2 4.00000
Anaphylaxis (13100), Course 3 1.02041
Anaphylaxis (13100), Course 4 3.33333
Anaphylaxis (13100), Course 5 1.13636
Anaphylaxis (13100), Course 6 0.00000
Back pain (16200), Course 1 4.80769
Back pain (16200), Course 2 5.00000
Back pain (16200), Course 3 3.06122
Back pain (16200), Course 4 3.33333
Back pain (16200), Course 5 4.54545
Back pain (16200), Course 6 0.00000
Capillary leak syndrome (19800) - Course 1 0.96154
Capillary leak syndrome (19800) - Course 2 4.00000
Capillary leak syndrome (19800) - Course 3 0.00000
Capillary leak syndrome (19800) - Course 4 2.22222
Capillary leak syndrome (19800) - Course 5 0.00000
Capillary leak syndrome (19800) - Course 6 0.00000
Chest wall pain (21400) - Course 1 0.00000
Chest wall pain (21400) - Course 2 0.00000
Chest wall pain (21400) - Course 3 1.02041
Chest wall pain (21400) - Course 4 0.00000
Chest wall pain (21400) - Course 5 1.13636
Chest wall pain (21400) - Course 6 0.00000
Fever (33900) - Course 1 21.1538
Fever (33900) - Course 2 58.0000
Fever (33900) - Course 3 6.1224
Fever (33900) - Course 4 31.1111
Fever (33900) - Course 5 4.5455
Fever (33900) - Course 6 1.2346
Flank pain (34200) - Course 1 0.96154
Flank pain (34200) - Course 2 0.00000
Flank pain (34200) - Course 3 0.00000
Flank pain (34200) - Course 4 0.00000
Flank pain (34200) - Course 5 0.00000
Flank pain (34200) - Course 6 0.00000
Hypotension (43600) - Course 1 9.6154
Hypotension (43600) - Course 2 17.0000
Hypotension (43600) - Course 3 4.0816
Hypotension (43600) - Course 4 14.4444
Hypotension (43600) - Course 5 7.9545
Hypotension (43600) - Course 6 0.00000
Neck pain (57800) - Course 1 0.96154
Neck pain (57800) - Course 2 3.00000
Neck pain (57800) - Course 3 0.00000
Neck pain (57800) - Course 4 0.00000
Neck pain (57800) - Course 5 1.13636
Neck pain (57800) - Course 6 0.00000
Non-cardiac chest pain (58600) - Course 1 0.96154
Non-cardiac chest pain (58600) - Course 2 0.00000
Non-cardiac chest pain (58600) - Course 3 0.00000
Non-cardiac chest pain (58600) - Course 4 0.00000
Non-cardiac chest pain (58600) - Course 5 0.00000
Non-cardiac chest pain (58600) - Course 6 0.00000
Pain (60600) - Course 1 23.0769
Pain (60600) - Course 2 16.0000
Pain (60600) - Course 3 13.2653
Pain (60600) - Course 4 20.0000
Pain (60600) - Course 5 11.3636
Pain (60600) - Course 6 1.2346
Pain in extremity (60700) - Course 1 4.80769
Pain in extremity (60700) - Course 2 4.00000
Pain in extremity (60700) - Course 3 3.06122
Pain in extremity (60700) - Course 4 6.66667
Pain in extremity (60700) - Course 5 2.27273
Pain in extremity (60700) - Course 6 1.23457
Peripheral sensory neuropathy (64100) - Course 1 0.96154
Peripheral sensory neuropathy (64100) - Course 2 0.00000
Peripheral sensory neuropathy (64100) - Course 3 1.02041
Peripheral sensory neuropathy (64100) - Course 4 0.00000
Peripheral sensory neuropathy (64100) - Course 5 0.00000
Peripheral sensory neuropathy (64100) - Course 6 0.00000
2.Secondary Outcome
Title Event-free Survival (EFS)
Hide Description Event-free Survival (EFS) for all eligible patients enrolled on the study
Time Frame From enrollment until the first occurrence of relapse, progressive disease, secondary malignancy, or death, or until last contact if no event occurred, up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients.
Arm/Group Title Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin
Hide Arm/Group Description:
Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 105
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
67.6
(58.2 to 77.0)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) for all eligible patients enrolled on the study
Time Frame From enrollment until death, or until last contact with the patient, up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients
Arm/Group Title Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin
Hide Arm/Group Description:
Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 105
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
79.1
(70.9 to 87.3)
Time Frame [Not Specified]
Adverse Event Reporting Description SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
 
Arm/Group Title Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin
Hide Arm/Group Description Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin
Affected / at Risk (%) # Events
Total   103/104 (99.04%)    
Blood and lymphatic system disorders   
13200-Anemia  65/104 (62.50%)  148
18100-Bone marrow hypocellular  1/104 (0.96%)  1
33300-Febrile neutropenia  6/104 (5.77%)  9
Cardiac disorders   
20000-Cardiac arrest  1/104 (0.96%)  1
74500-Sinus tachycardia  1/104 (0.96%)  1
Ear and labyrinth disorders   
28000-Ear pain  1/104 (0.96%)  1
38900-Hearing impaired  9/104 (8.65%)  9
Gastrointestinal disorders   
10300-Abdominal pain  21/104 (20.19%)  56
12800-Anal pain  1/104 (0.96%)  1
22100-Colitis  1/104 (0.96%)  1
22400-Colonic obstruction  1/104 (0.96%)  1
25700-Diarrhea  15/104 (14.42%)  20
27600-Dysphagia  1/104 (0.96%)  1
44200-Ileal obstruction  1/104 (0.96%)  1
53900-Malabsorption  1/104 (0.96%)  1
55600-Mucositis oral  1/104 (0.96%)  1
57600-Nausea  2/104 (1.92%)  2
81900-Typhlitis  2/104 (1.92%)  2
87900-Vomiting  4/104 (3.85%)  7
General disorders   
28200-Edema face  1/104 (0.96%)  1
33900-Fever  69/104 (66.35%)  204
37200-General disorders and administration site conditions - Other  1/104 (0.96%)  1
48700-Irritability  3/104 (2.88%)  3
58600-Non-cardiac chest pain  1/104 (0.96%)  2
60600-Pain  46/104 (44.23%)  134
Immune system disorders   
12000-Allergic reaction  9/104 (8.65%)  13
13100-Anaphylaxis  9/104 (8.65%)  11
24400-Cytokine release syndrome  1/104 (0.96%)  1
Infections and infestations   
20500-Catheter related infection  33/104 (31.73%)  63
25600-Device related infection  4/104 (3.85%)  4
29500-Enterocolitis infectious  3/104 (2.88%)  3
44800-Infections and infestations - Other  16/104 (15.38%)  23
53100-Lung infection  5/104 (4.81%)  7
60100-Otitis media  2/104 (1.92%)  3
73700-Sepsis  1/104 (0.96%)  1
75200-Skin infection  3/104 (2.88%)  3
76000-Small intestine infection  1/104 (0.96%)  1
82300-Upper respiratory infection  2/104 (1.92%)  2
83100-Urinary tract infection  4/104 (3.85%)  4
Injury, poisoning and procedural complications   
86400-Vascular access complication  1/104 (0.96%)  1
Investigations   
10900-Activated partial thromboplastin time prolonged  2/104 (1.92%)  2
11600-Alanine aminotransferase increased  24/104 (23.08%)  49
11800-Alkaline phosphatase increased  2/104 (1.92%)  2
15000-Aspartate aminotransferase increased  11/104 (10.58%)  17
17400-Blood bilirubin increased  2/104 (1.92%)  6
24100-Creatinine increased  2/104 (1.92%)  2
37500-GGT increased  11/104 (10.58%)  27
53700-Lymphocyte count decreased  78/104 (75.00%)  339
53800-Lymphocyte count increased  4/104 (3.85%)  4
58300-Neutrophil count decreased  55/104 (52.88%)  193
65800-Platelet count decreased  58/104 (55.77%)  355
83600-Urine output decreased  5/104 (4.81%)  5
88200-Weight gain  2/104 (1.92%)  2
88300-Weight loss  4/104 (3.85%)  7
88500-White blood cell decreased  25/104 (24.04%)  82
Metabolism and nutrition disorders   
10700-Acidosis  5/104 (4.81%)  6
13500-Anorexia  23/104 (22.12%)  25
24700-Dehydration  5/104 (4.81%)  5
41300-Hypercalcemia  5/104 (4.81%)  7
41400-Hyperglycemia  11/104 (10.58%)  13
41600-Hyperkalemia  7/104 (6.73%)  10
41700-Hypermagnesemia  1/104 (0.96%)  1
41800-Hypernatremia  1/104 (0.96%)  1
42400-Hypertriglyceridemia  2/104 (1.92%)  3
42600-Hypoalbuminemia  9/104 (8.65%)  11
42700-Hypocalcemia  5/104 (4.81%)  5
42900-Hypoglycemia  2/104 (1.92%)  2
43100-Hypokalemia  51/104 (49.04%)  117
43300-Hyponatremia  42/104 (40.38%)  63
43500-Hypophosphatemia  17/104 (16.35%)  17
Musculoskeletal and connective tissue disorders   
16200-Back pain  10/104 (9.62%)  23
21400-Chest wall pain  1/104 (0.96%)  3
34200-Flank pain  1/104 (0.96%)  1
57800-Neck pain  4/104 (3.85%)  6
60700-Pain in extremity  17/104 (16.35%)  34
Nervous system disorders   
15300-Ataxia  1/104 (0.96%)  1
25300-Depressed level of consciousness  1/104 (0.96%)  1
38800-Headache  6/104 (5.77%)  7
42000-Hypersomnia  1/104 (0.96%)  1
58200-Neuralgia  8/104 (7.69%)  23
59000-Oculomotor nerve disorder  1/104 (0.96%)  1
63900-Peripheral motor neuropathy  1/104 (0.96%)  1
64100-Peripheral sensory neuropathy  2/104 (1.92%)  2
76700-Somnolence  2/104 (1.92%)  2
Psychiatric disorders   
11400-Agitation  4/104 (3.85%)  9
13700-Anxiety  2/104 (1.92%)  2
25000-Delirium  1/104 (0.96%)  1
38500-Hallucinations  1/104 (0.96%)  1
Renal and urinary disorders   
11100-Acute kidney injury  1/104 (0.96%)  1
68300-Proteinuria  1/104 (0.96%)  2
83000-Urinary retention  1/104 (0.96%)  1
Respiratory, thoracic and mediastinal disorders   
14100-Apnea  2/104 (1.92%)  2
19300-Bronchospasm  4/104 (3.85%)  5
23800-Cough  2/104 (1.92%)  2
27800-Dyspnea  12/104 (11.54%)  25
43900-Hypoxia  29/104 (27.88%)  58
68700-Pulmonary edema  1/104 (0.96%)  1
71600-Respiratory thoracic and mediastinal disorders - Other  2/104 (1.92%)  5
78100-Stridor  4/104 (3.85%)  4
88400-Wheezing  2/104 (1.92%)  3
Skin and subcutaneous tissue disorders   
26200-Dry skin  1/104 (0.96%)  1
63600-Periorbital edema  1/104 (0.96%)  1
68400-Pruritus  3/104 (2.88%)  6
69700-Rash maculo-papular  1/104 (0.96%)  1
84100-Urticaria  11/104 (10.58%)  22
Surgical and medical procedures   
79000-Surgical and medical procedures - Other  1/104 (0.96%)  1
Vascular disorders   
19800-Capillary leak syndrome  7/104 (6.73%)  7
42100-Hypertension  4/104 (3.85%)  5
43600-Hypotension  33/104 (31.73%)  67
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%
Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin
Affected / at Risk (%) # Events
Total   104/104 (100.00%)    
Blood and lymphatic system disorders   
13200-Anemia  99/104 (95.19%)  1181
17200-Blood and lymphatic system disorders - Other  2/104 (1.92%)  2
18100-Bone marrow hypocellular  1/104 (0.96%)  1
25800-Disseminated intravascular coagulation  1/104 (0.96%)  1
Cardiac disorders   
20100-Cardiac disorders - Other  6/104 (5.77%)  16
21300-Chest pain - cardiac  3/104 (2.88%)  3
61000-Palpitations  2/104 (1.92%)  2
63100-Pericardial effusion  2/104 (1.92%)  3
74200-Sinus bradycardia  7/104 (6.73%)  18
74500-Sinus tachycardia  85/104 (81.73%)  740
78900-Supraventricular tachycardia  3/104 (2.88%)  5
81400-Tricuspid valve disease  1/104 (0.96%)  1
Ear and labyrinth disorders   
27900-Ear and labyrinth disorders - Other  2/104 (1.92%)  2
28000-Ear pain  3/104 (2.88%)  3
31600-External ear pain  1/104 (0.96%)  1
38900-Hearing impaired  10/104 (9.62%)  10
Endocrine disorders   
11200-Adrenal insufficiency  1/104 (0.96%)  1
29200-Endocrine disorders - Other  1/104 (0.96%)  1
41900-Hyperparathyroidism  1/104 (0.96%)  1
42200-Hyperthyroidism  5/104 (4.81%)  5
43400-Hypoparathyroidism  1/104 (0.96%)  1
43800-Hypothyroidism  5/104 (4.81%)  7
Eye disorders   
17800-Blurred vision  5/104 (4.81%)  7
23200-Conjunctivitis  1/104 (0.96%)  1
26000-Dry eye  3/104 (2.88%)  3
31900-Eye disorders - Other  13/104 (12.50%)  14
32100-Eye pain  5/104 (4.81%)  5
32200-Eyelid function disorder  1/104 (0.96%)  1
59300-Optic nerve disorder  2/104 (1.92%)  2
61900-Papilledema  1/104 (0.96%)  1
65600-Photophobia  3/104 (2.88%)  3
73200-Scleral disorder  1/104 (0.96%)  1
Gastrointestinal disorders   
10100-Abdominal distension  14/104 (13.46%)  27
10300-Abdominal pain  70/104 (67.31%)  284
12800-Anal pain  2/104 (1.92%)  2
17100-Bloating  1/104 (0.96%)  1
21200-Cheilitis  10/104 (9.62%)  14
22100-Colitis  1/104 (0.96%)  1
23400-Constipation  36/104 (34.62%)  72
25700-Diarrhea  60/104 (57.69%)  203
26100-Dry mouth  3/104 (2.88%)  3
27500-Dyspepsia  2/104 (1.92%)  2
27600-Dysphagia  4/104 (3.85%)  4
29400-Enterocolitis  4/104 (3.85%)  4
34400-Flatulence  5/104 (4.81%)  7
36400-Gastritis  6/104 (5.77%)  7
36500-Gastroesophageal reflux disease  3/104 (2.88%)  3
36700-Gastrointestinal disorders - Other  5/104 (4.81%)  8
36900-Gastrointestinal pain  1/104 (0.96%)  1
37600-Gingival pain  1/104 (0.96%)  1
39800-Hemorrhoidal hemorrhage  1/104 (0.96%)  1
55600-Mucositis oral  3/104 (2.88%)  3
57600-Nausea  55/104 (52.88%)  188
59700-Oral pain  4/104 (3.85%)  4
70800-Rectal ulcer  1/104 (0.96%)  1
77900-Stomach pain  7/104 (6.73%)  13
80200-Toothache  2/104 (1.92%)  2
87900-Vomiting  65/104 (62.50%)  309
General disorders   
21500-Chills  21/104 (20.19%)  34
28200-Edema face  56/104 (53.85%)  110
28300-Edema limbs  36/104 (34.62%)  61
28400-Edema trunk  5/104 (4.81%)  6
32500-Facial pain  2/104 (1.92%)  2
33200-Fatigue  34/104 (32.69%)  73
33900-Fever  102/104 (98.08%)  1117
34600-Flu like symptoms  2/104 (1.92%)  7
35000-Gait disturbance  3/104 (2.88%)  5
37200-General disorders and administration site conditions - Other  4/104 (3.85%)  7
43700-Hypothermia  1/104 (0.96%)  2
45000-Infusion related reaction  4/104 (3.85%)  10
45200-Injection site reaction  16/104 (15.38%)  23
48700-Irritability  33/104 (31.73%)  74
52800-Localized edema  10/104 (9.62%)  14
54000-Malaise  4/104 (3.85%)  4
58600-Non-cardiac chest pain  6/104 (5.77%)  7
60600-Pain  82/104 (78.85%)  746
Immune system disorders   
12000-Allergic reaction  33/104 (31.73%)  123
24400-Cytokine release syndrome  2/104 (1.92%)  2
Infections and infestations   
18800-Bronchial infection  1/104 (0.96%)  1
20500-Catheter related infection  5/104 (4.81%)  6
23300-Conjunctivitis infective  1/104 (0.96%)  1
29500-Enterocolitis infectious  9/104 (8.65%)  13
30400-Esophageal infection  1/104 (0.96%)  1
44800-Infections and infestations - Other  21/104 (20.19%)  28
53100-Lung infection  3/104 (2.88%)  3
55500-Mucosal infection  1/104 (0.96%)  1
57200-Nail infection  1/104 (0.96%)  1
60100-Otitis media  4/104 (3.85%)  5
62000-Papulopustular rash  1/104 (0.96%)  1
62200-Paronychia  1/104 (0.96%)  3
65200-Pharyngitis  3/104 (2.88%)  5
72600-Rhinitis infective  3/104 (2.88%)  4
74600-Sinusitis  2/104 (1.92%)  2
75200-Skin infection  6/104 (5.77%)  8
76000-Small intestine infection  1/104 (0.96%)  1
82300-Upper respiratory infection  9/104 (8.65%)  11
83100-Urinary tract infection  6/104 (5.77%)  8
Injury, poisoning and procedural complications   
19400-Bruising  8/104 (7.69%)  9
25500-Dermatitis radiation  2/104 (1.92%)  2
45700-Injury poisoning and procedural complications - Other  2/104 (1.92%)  3
66800-Postoperative hemorrhage  1/104 (0.96%)  1
86400-Vascular access complication  8/104 (7.69%)  13
Investigations   
10900-Activated partial thromboplastin time prolonged  8/104 (7.69%)  10
11600-Alanine aminotransferase increased  90/104 (86.54%)  507
11800-Alkaline phosphatase increased  20/104 (19.23%)  64
15000-Aspartate aminotransferase increased  91/104 (87.50%)  399
17400-Blood bilirubin increased  15/104 (14.42%)  40
21700-Cholesterol high  3/104 (2.88%)  3
24100-Creatinine increased  31/104 (29.81%)  137
28700-Electrocardiogram QT corrected interval prolonged  1/104 (0.96%)  1
37500-GGT increased  20/104 (19.23%)  87
39400-Hemoglobin increased  9/104 (8.65%)  29
45800-INR increased  5/104 (4.81%)  5
48400-Investigations - Other  3/104 (2.88%)  6
53700-Lymphocyte count decreased  87/104 (83.65%)  904
53800-Lymphocyte count increased  4/104 (3.85%)  4
58300-Neutrophil count decreased  67/104 (64.42%)  376
65800-Platelet count decreased  97/104 (93.27%)  780
88200-Weight gain  56/104 (53.85%)  227
88300-Weight loss  21/104 (20.19%)  54
88500-White blood cell decreased  89/104 (85.58%)  737
Metabolism and nutrition disorders   
10700-Acidosis  3/104 (2.88%)  10
13500-Anorexia  32/104 (30.77%)  84
24700-Dehydration  13/104 (12.50%)  16
41300-Hypercalcemia  26/104 (25.00%)  48
41400-Hyperglycemia  61/104 (58.65%)  195
41600-Hyperkalemia  35/104 (33.65%)  71
41700-Hypermagnesemia  17/104 (16.35%)  52
41800-Hypernatremia  12/104 (11.54%)  18
42400-Hypertriglyceridemia  84/104 (80.77%)  205
42500-Hyperuricemia  2/104 (1.92%)  2
42600-Hypoalbuminemia  101/104 (97.12%)  890
42700-Hypocalcemia  96/104 (92.31%)  579
42900-Hypoglycemia  43/104 (41.35%)  95
43100-Hypokalemia  85/104 (81.73%)  392
43200-Hypomagnesemia  41/104 (39.42%)  119
43300-Hyponatremia  95/104 (91.35%)  524
43500-Hypophosphatemia  69/104 (66.35%)  211
54900-Metabolism and nutrition disorders - Other  2/104 (1.92%)  5
Musculoskeletal and connective tissue disorders   
14700-Arthralgia  2/104 (1.92%)  2
16200-Back pain  25/104 (24.04%)  70
18200-Bone pain  5/104 (4.81%)  5
19700-Buttock pain  4/104 (3.85%)  4
21400-Chest wall pain  6/104 (5.77%)  22
37300-Generalized muscle weakness  2/104 (1.92%)  3
49800-Joint range of motion decreased  1/104 (0.96%)  1
55900-Muscle weakness lower limb  1/104 (0.96%)  1
56300-Musculoskeletal and connective tissue disorder - Other  2/104 (1.92%)  6
56500-Myalgia  10/104 (9.62%)  11
57800-Neck pain  14/104 (13.46%)  32
60700-Pain in extremity  48/104 (46.15%)  155
Nervous system disorders   
11500-Akathisia  2/104 (1.92%)  2
22000-Cognitive disturbance  1/104 (0.96%)  1
22800-Concentration impairment  1/104 (0.96%)  1
25300-Depressed level of consciousness  1/104 (0.96%)  1
25900-Dizziness  3/104 (2.88%)  5
38800-Headache  31/104 (29.81%)  76
42000-Hypersomnia  1/104 (0.96%)  1
51800-Lethargy  5/104 (4.81%)  5
54400-Memory impairment  1/104 (0.96%)  1
54500-Meningismus  1/104 (0.96%)  2
55400-Movements involuntary  4/104 (3.85%)  4
58100-Nervous system disorders - Other  2/104 (1.92%)  3
58200-Neuralgia  5/104 (4.81%)  13
58700-Nystagmus  1/104 (0.96%)  1
59000-Oculomotor nerve disorder  1/104 (0.96%)  1
62100-Paresthesia  2/104 (1.92%)  2
64100-Peripheral sensory neuropathy  11/104 (10.58%)  16
73600-Seizure  2/104 (1.92%)  2
76700-Somnolence  7/104 (6.73%)  7
81300-Tremor  3/104 (2.88%)  3
Pregnancy, puerperium and perinatal conditions   
67200-Premature delivery  1/104 (0.96%)  1
Psychiatric disorders   
11400-Agitation  24/104 (23.08%)  40
13700-Anxiety  14/104 (13.46%)  23
23000-Confusion  7/104 (6.73%)  10
25400-Depression  3/104 (2.88%)  6
38500-Hallucinations  10/104 (9.62%)  14
45900-Insomnia  7/104 (6.73%)  8
54100-Mania  1/104 (0.96%)  1
68500-Psychiatric disorders - Other  3/104 (2.88%)  3
71700-Restlessness  4/104 (3.85%)  6
Renal and urinary disorders   
11100-Acute kidney injury  2/104 (1.92%)  3
21800-Chronic kidney disease  1/104 (0.96%)  1
39300-Hematuria  36/104 (34.62%)  93
68300-Proteinuria  43/104 (41.35%)  144
71000-Renal and urinary disorders - Other  2/104 (1.92%)  4
82800-Urinary frequency  1/104 (0.96%)  1
82900-Urinary incontinence  1/104 (0.96%)  1
83000-Urinary retention  30/104 (28.85%)  63
83300-Urinary tract pain  4/104 (3.85%)  9
83400-Urinary urgency  1/104 (0.96%)  1
83500-Urine discoloration  5/104 (4.81%)  13
Reproductive system and breast disorders   
37400-Genital edema  1/104 (0.96%)  4
62600-Pelvic pain  1/104 (0.96%)  1
62900-Penile pain  2/104 (1.92%)  3
71400-Reproductive system and breast disorders - Other  1/104 (0.96%)  3
85600-Vaginal inflammation  1/104 (0.96%)  1
Respiratory, thoracic and mediastinal disorders   
12100-Allergic rhinitis  15/104 (14.42%)  18
15400-Atelectasis  6/104 (5.77%)  9
19000-Bronchial stricture  2/104 (1.92%)  2
19300-Bronchospasm  10/104 (9.62%)  16
23800-Cough  74/104 (71.15%)  220
27800-Dyspnea  8/104 (7.69%)  11
29700-Epistaxis  4/104 (3.85%)  6
40700-Hiccups  1/104 (0.96%)  1
41000-Hoarseness  2/104 (1.92%)  2
43900-Hypoxia  32/104 (30.77%)  99
51500-Laryngopharyngeal dysesthesia  1/104 (0.96%)  1
51600-Laryngospasm  1/104 (0.96%)  1
57500-Nasal congestion  23/104 (22.12%)  39
65300-Pharyngolaryngeal pain  2/104 (1.92%)  2
65900-Pleural effusion  4/104 (3.85%)  5
66200-Pleuritic pain  1/104 (0.96%)  3
66300-Pneumonitis  3/104 (2.88%)  3
66700-Postnasal drip  1/104 (0.96%)  1
67600-Productive cough  4/104 (3.85%)  4
68700-Pulmonary edema  3/104 (2.88%)  3
71600-Respiratory thoracic and mediastinal disorders - Other  34/104 (32.69%)  242
72200-Retinoic acid syndrome  1/104 (0.96%)  1
76200-Sneezing  6/104 (5.77%)  6
76800-Sore throat  7/104 (6.73%)  12
88400-Wheezing  17/104 (16.35%)  37
Skin and subcutaneous tissue disorders   
12200-Alopecia  28/104 (26.92%)  36
19500-Bullous dermatitis  1/104 (0.96%)  1
26200-Dry skin  69/104 (66.35%)  175
29900-Erythema multiforme  8/104 (7.69%)  11
42300-Hypertrichosis  1/104 (0.96%)  1
57300-Nail loss  1/104 (0.96%)  1
60900-Palmar-plantar erythrodysesthesia syndrome  1/104 (0.96%)  1
63600-Periorbital edema  16/104 (15.38%)  27
65700-Photosensitivity  2/104 (1.92%)  2
68400-Pruritus  62/104 (59.62%)  223
69600-Rash acneiform  5/104 (4.81%)  6
69700-Rash maculo-papular  58/104 (55.77%)  130
74700-Skin and subcutaneous tissue disorders - Other  20/104 (19.23%)  51
74800-Skin atrophy  1/104 (0.96%)  1
74900-Skin hyperpigmentation  2/104 (1.92%)  2
75000-Skin hypopigmentation  2/104 (1.92%)  4
75100-Skin induration  3/104 (2.88%)  3
75300-Skin ulceration  4/104 (3.85%)  4
84100-Urticaria  46/104 (44.23%)  139
Vascular disorders   
19800-Capillary leak syndrome  53/104 (50.96%)  131
34700-Flushing  8/104 (7.69%)  10
41100-Hot flashes  2/104 (1.92%)  2
42100-Hypertension  56/104 (53.85%)  406
43600-Hypotension  81/104 (77.88%)  768
79600-Thromboembolic event  1/104 (0.96%)  1
86500-Vascular disorders - Other  3/104 (2.88%)  10
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01041638     History of Changes
Other Study ID Numbers: NCI-2011-01997
NCI-2011-01997 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ANBL0931
CDR0000662673
ANBL0931
ANBL0931 ( Other Identifier: Childrens Oncology Group )
ANBL0931 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: December 31, 2009
First Posted: January 1, 2010
Results First Submitted: February 3, 2015
Results First Posted: February 19, 2015
Last Update Posted: May 8, 2019