Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 99 of 115 for:    cancer | butyrate

Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma

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: NCT00057811
Recruitment Status : Completed
First Posted : April 9, 2003
Results First Posted : August 22, 2014
Last Update Posted : September 19, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Childhood Burkitt Lymphoma
Childhood Diffuse Large Cell Lymphoma
Childhood Immunoblastic Large Cell Lymphoma
Stage I Childhood Large Cell Lymphoma
Stage I Childhood Small Noncleaved Cell Lymphoma
Stage II Childhood Large Cell Lymphoma
Stage II Childhood Small Noncleaved Cell Lymphoma
Stage III Childhood Large Cell Lymphoma
Stage III Childhood Small Noncleaved Cell Lymphoma
Stage IV Childhood Large Cell Lymphoma
Stage IV Childhood Small Noncleaved Cell Lymphoma
Untreated Childhood Acute Lymphoblastic Leukemia
Interventions Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: methotrexate
Drug: rasburicase
Drug: leucovorin calcium
Drug: prednisone
Drug: methylprednisolone
Biological: filgrastim
Biological: rituximab
Drug: cytarabine
Drug: etoposide
Drug: vincristine sulfate
Drug: hydrocortisone sodium succinate
Other: laboratory biomarker analysis
Enrollment 97
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) Group C (Chemotherapy, Monoclonal Antibody Therapy)
Hide Arm/Group Description Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description. Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Period Title: Overall Study
Started 51 46
Completed 41 34
Not Completed 10 12
Reason Not Completed
Lack of Efficacy             1             4
Physician Decision             1             0
Withdrawal by Subject             3             4
Ineligible             4             2
Inevaluable             1             2
Arm/Group Title Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) Group C (Chemotherapy, Monoclonal Antibody Therapy) Total
Hide Arm/Group Description Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description. Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description. Total of all reporting groups
Overall Number of Baseline Participants 51 46 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 46 participants 97 participants
<=18 years
49
  96.1%
44
  95.7%
93
  95.9%
Between 18 and 65 years
2
   3.9%
2
   4.3%
4
   4.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Days
Number Analyzed 51 participants 46 participants 97 participants
4575
(2497 to 5638)
3132
(1940 to 4419)
3853.5
(2218.5 to 5028.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 46 participants 97 participants
Female
10
  19.6%
9
  19.6%
19
  19.6%
Male
41
  80.4%
37
  80.4%
78
  80.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 46 participants 97 participants
Hispanic or Latino
12
  23.5%
7
  15.2%
19
  19.6%
Not Hispanic or Latino
39
  76.5%
36
  78.3%
75
  77.3%
Unknown or Not Reported
0
   0.0%
3
   6.5%
3
   3.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 46 participants 97 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   7.8%
4
   8.7%
8
   8.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   5.9%
5
  10.9%
8
   8.2%
White
40
  78.4%
34
  73.9%
74
  76.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   7.8%
3
   6.5%
7
   7.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 46 participants 97 participants
United States 47 38 85
Australia 1 3 4
Canada 3 5 8
1.Primary Outcome
Title Grade ≥ 3 Stomatitis
Hide Description The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.
Arm/Group Title Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) Group C (Chemotherapy, Monoclonal Antibody Therapy)
Hide Arm/Group Description:
Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Overall Number of Participants Analyzed 45 40
Measure Type: Number
Unit of Measure: participants
Incidence of grade ≥ 3 stomatitis 4 6
No incidence of grade ≥ 3 stomatitis 41 34
2.Primary Outcome
Title Response Rate
Hide Description Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present..
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed includes eligible patients considered evaluable for response (with measurable disease at on study and adequate assessment of response).
Arm/Group Title Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) Group C (Chemotherapy, Monoclonal Antibody Therapy)
Hide Arm/Group Description:
Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Overall Number of Participants Analyzed 32 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants analyzed
88
(71 to 96)
83
(61 to 95)
3.Primary Outcome
Title Minimal Residual Disease
Hide Description The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section).
Time Frame Not Provided
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included patients submitting samples for minimal disease assay at end induction
Arm/Group Title Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) Group C (Chemotherapy, Monoclonal Antibody Therapy)
Hide Arm/Group Description:
Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Overall Number of Participants Analyzed 32 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of samples analyzed
22
(11 to 40)
70
(35 to 93)
4.Primary Outcome
Title Toxic Death
Hide Description Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.
Arm/Group Title Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) Group C (Chemotherapy, Monoclonal Antibody Therapy)
Hide Arm/Group Description:
Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
Overall Number of Participants Analyzed 45 40
Measure Type: Number
Unit of Measure: participants
Toxic death 0 2
No toxic death 45 38
Time Frame [Not Specified]
Adverse Event Reporting Description For Group B, 46 participants are reported for adverse events as 5 patients were declared ineligible. For Group C, 42 participants are reported for adverse events as 4 patients were declared ineligible.
 
Arm/Group Title Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) Group C (Chemotherapy, Monoclonal Antibody Therapy)
Hide Arm/Group Description Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description. Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
All-Cause Mortality
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) Group C (Chemotherapy, Monoclonal Antibody Therapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) Group C (Chemotherapy, Monoclonal Antibody Therapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/46 (4.35%)      6/42 (14.29%)    
Blood and lymphatic system disorders     
Anemia  1/46 (2.17%)  1 0/42 (0.00%)  0
Febrile neutropenia  2/46 (4.35%)  2 1/42 (2.38%)  1
Cardiac disorders     
Cardiac disorders - Other, specify  0/46 (0.00%)  0 1/42 (2.38%)  1
Sinus tachycardia  0/46 (0.00%)  0 1/42 (2.38%)  1
Eye disorders     
Photophobia  1/46 (2.17%)  1 0/42 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  0/46 (0.00%)  0 2/42 (4.76%)  2
Colitis  1/46 (2.17%)  1 1/42 (2.38%)  1
Esophageal pain  1/46 (2.17%)  1 0/42 (0.00%)  0
Esophagitis  1/46 (2.17%)  1 0/42 (0.00%)  0
Mucositis oral  1/46 (2.17%)  1 6/42 (14.29%)  6
Nausea  0/46 (0.00%)  0 1/42 (2.38%)  1
Oral pain  0/46 (0.00%)  0 1/42 (2.38%)  1
Typhlitis  0/46 (0.00%)  0 2/42 (4.76%)  2
Immune system disorders     
Anaphylaxis  0/46 (0.00%)  0 1/42 (2.38%)  1
Infections and infestations     
Enterocolitis infectious  1/46 (2.17%)  1 1/42 (2.38%)  1
Infections and infestations - Other, specify  0/46 (0.00%)  0 3/42 (7.14%)  3
Lung infection  0/46 (0.00%)  0 1/42 (2.38%)  1
Investigations     
Alanine aminotransferase increased  0/46 (0.00%)  0 3/42 (7.14%)  3
Aspartate aminotransferase increased  0/46 (0.00%)  0 3/42 (7.14%)  3
Blood bilirubin increased  0/46 (0.00%)  0 1/42 (2.38%)  1
Creatinine increased  0/46 (0.00%)  0 1/42 (2.38%)  1
Neutrophil count decreased  1/46 (2.17%)  1 0/42 (0.00%)  0
Platelet count decreased  1/46 (2.17%)  1 0/42 (0.00%)  0
Weight loss  0/46 (0.00%)  0 1/42 (2.38%)  1
White blood cell decreased  1/46 (2.17%)  1 1/42 (2.38%)  1
Metabolism and nutrition disorders     
Acidosis  0/46 (0.00%)  0 1/42 (2.38%)  1
Anorexia  0/46 (0.00%)  0 3/42 (7.14%)  3
Dehydration  0/46 (0.00%)  0 1/42 (2.38%)  1
Glucose intolerance  0/46 (0.00%)  0 1/42 (2.38%)  1
Hyperglycemia  0/46 (0.00%)  0 2/42 (4.76%)  2
Hyperkalemia  0/46 (0.00%)  0 1/42 (2.38%)  1
Hypokalemia  1/46 (2.17%)  1 1/42 (2.38%)  1
Hyponatremia  0/46 (0.00%)  0 1/42 (2.38%)  1
Tumor lysis syndrome  0/46 (0.00%)  0 2/42 (4.76%)  2
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorder - Other, specify  0/46 (0.00%)  0 1/42 (2.38%)  1
Nervous system disorders     
Dizziness  1/46 (2.17%)  1 0/42 (0.00%)  0
Headache  1/46 (2.17%)  1 0/42 (0.00%)  0
Seizure  0/46 (0.00%)  0 1/42 (2.38%)  1
Renal and urinary disorders     
Acute kidney injury  0/46 (0.00%)  0 1/42 (2.38%)  1
Cystitis noninfective  0/46 (0.00%)  0 1/42 (2.38%)  1
Urinary frequency  0/46 (0.00%)  0 1/42 (2.38%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea  0/46 (0.00%)  0 1/42 (2.38%)  1
Epistaxis  0/46 (0.00%)  0 1/42 (2.38%)  1
Hypoxia  0/46 (0.00%)  0 1/42 (2.38%)  1
Pharyngeal mucositis  1/46 (2.17%)  1 0/42 (0.00%)  0
Vascular disorders     
Hypertension  1/46 (2.17%)  1 0/42 (0.00%)  0
Hypotension  0/46 (0.00%)  0 1/42 (2.38%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.) Group C (Chemotherapy, Monoclonal Antibody Therapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/46 (69.57%)      35/42 (83.33%)    
Blood and lymphatic system disorders     
Anemia  32/46 (69.57%)  32 32/42 (76.19%)  32
Blood and lymphatic system disorders - Other, specify  0/46 (0.00%)  0 1/42 (2.38%)  1
Bone marrow hypocellular  0/46 (0.00%)  0 1/42 (2.38%)  1
Disseminated intravascular coagulation  0/46 (0.00%)  0 1/42 (2.38%)  1
Febrile neutropenia  18/46 (39.13%)  18 22/42 (52.38%)  22
Cardiac disorders     
Asystole  0/46 (0.00%)  0 1/42 (2.38%)  1
Cardiac disorders - Other, specify  1/46 (2.17%)  1 2/42 (4.76%)  2
Mobitz type I  0/46 (0.00%)  0 1/42 (2.38%)  1
Sinus bradycardia  0/46 (0.00%)  0 1/42 (2.38%)  1
Sinus tachycardia  1/46 (2.17%)  1 2/42 (4.76%)  2
Ear and labyrinth disorders     
External ear inflammation  0/46 (0.00%)  0 1/42 (2.38%)  1
Hearing impaired  0/46 (0.00%)  0 1/42 (2.38%)  1
Eye disorders     
Blurred vision  0/46 (0.00%)  0 2/42 (4.76%)  2
Conjunctivitis  0/46 (0.00%)  0 2/42 (4.76%)  2
Dry eye  2/46 (4.35%)  2 0/42 (0.00%)  0
Extraocular muscle paresis  0/46 (0.00%)  0 1/42 (2.38%)  1
Eye disorders - Other, specify  0/46 (0.00%)  0 2/42 (4.76%)  2
Eye pain  0/46 (0.00%)  0 1/42 (2.38%)  1
Photophobia  1/46 (2.17%)  1 1/42 (2.38%)  1
Gastrointestinal disorders     
Abdominal distension  0/46 (0.00%)  0 2/42 (4.76%)  2
Abdominal pain  8/46 (17.39%)  8 11/42 (26.19%)  11
Anal mucositis  3/46 (6.52%)  3 0/42 (0.00%)  0
Colitis  1/46 (2.17%)  1 1/42 (2.38%)  1
Constipation  5/46 (10.87%)  5 6/42 (14.29%)  6
Diarrhea  6/46 (13.04%)  6 13/42 (30.95%)  13
Dry mouth  0/46 (0.00%)  0 2/42 (4.76%)  2
Dyspepsia  3/46 (6.52%)  3 2/42 (4.76%)  2
Dysphagia  0/46 (0.00%)  0 2/42 (4.76%)  2
Esophageal pain  1/46 (2.17%)  1 0/42 (0.00%)  0
Esophagitis  1/46 (2.17%)  1 1/42 (2.38%)  1
Gastric hemorrhage  1/46 (2.17%)  1 0/42 (0.00%)  0
Gastritis  0/46 (0.00%)  0 2/42 (4.76%)  2
Gastrointestinal disorders - Other, specify  2/46 (4.35%)  2 3/42 (7.14%)  3
Gingival pain  1/46 (2.17%)  1 0/42 (0.00%)  0
Hemorrhoids  1/46 (2.17%)  1 0/42 (0.00%)  0
Ileus  0/46 (0.00%)  0 2/42 (4.76%)  2
Lower gastrointestinal hemorrhage  2/46 (4.35%)  2 0/42 (0.00%)  0
Mucositis oral  19/46 (41.30%)  19 18/42 (42.86%)  18
Nausea  10/46 (21.74%)  10 15/42 (35.71%)  15
Oral hemorrhage  0/46 (0.00%)  0 3/42 (7.14%)  3
Oral pain  3/46 (6.52%)  3 7/42 (16.67%)  7
Rectal hemorrhage  1/46 (2.17%)  1 0/42 (0.00%)  0
Rectal mucositis  1/46 (2.17%)  1 0/42 (0.00%)  0
Rectal pain  3/46 (6.52%)  3 1/42 (2.38%)  1
Stomach pain  0/46 (0.00%)  0 2/42 (4.76%)  2
Vomiting  8/46 (17.39%)  8 13/42 (30.95%)  13
General disorders     
Chills  2/46 (4.35%)  2 2/42 (4.76%)  2
Edema limbs  0/46 (0.00%)  0 4/42 (9.52%)  4
Fatigue  1/46 (2.17%)  1 7/42 (16.67%)  7
Fever  4/46 (8.70%)  4 11/42 (26.19%)  11
Flu like symptoms  0/46 (0.00%)  0 1/42 (2.38%)  1
Gait disturbance  0/46 (0.00%)  0 1/42 (2.38%)  1
General disorders and administration site conditions - Other, specify  1/46 (2.17%)  1 1/42 (2.38%)  1
Pain  7/46 (15.22%)  7 5/42 (11.90%)  5
Hepatobiliary disorders     
Hepatic pain  0/46 (0.00%)  0 1/42 (2.38%)  1
Immune system disorders     
Allergic reaction  5/46 (10.87%)  5 2/42 (4.76%)  2
Anaphylaxis  1/46 (2.17%)  1 1/42 (2.38%)  1
Infections and infestations     
Catheter related infection  1/46 (2.17%)  1 5/42 (11.90%)  5
Enterocolitis infectious  5/46 (10.87%)  5 1/42 (2.38%)  1
Infections and infestations - Other, specify  16/46 (34.78%)  16 23/42 (54.76%)  23
Lip infection  0/46 (0.00%)  0 1/42 (2.38%)  1
Lung infection  0/46 (0.00%)  0 2/42 (4.76%)  2
Mucosal infection  1/46 (2.17%)  1 0/42 (0.00%)  0
Otitis externa  0/46 (0.00%)  0 1/42 (2.38%)  1
Otitis media  1/46 (2.17%)  1 1/42 (2.38%)  1
Pharyngitis  1/46 (2.17%)  1 0/42 (0.00%)  0
Sinusitis  0/46 (0.00%)  0 3/42 (7.14%)  3
Skin infection  0/46 (0.00%)  0 1/42 (2.38%)  1
Small intestine infection  1/46 (2.17%)  1 0/42 (0.00%)  0
Tooth infection  0/46 (0.00%)  0 1/42 (2.38%)  1
Urinary tract infection  1/46 (2.17%)  1 1/42 (2.38%)  1
Injury, poisoning and procedural complications     
Bruising  0/46 (0.00%)  0 1/42 (2.38%)  1
Fracture  0/46 (0.00%)  0 1/42 (2.38%)  1
Vascular access complication  2/46 (4.35%)  2 0/42 (0.00%)  0
Venous injury  0/46 (0.00%)  0 1/42 (2.38%)  1
Investigations     
Activated partial thromboplastin time prolonged  2/46 (4.35%)  2 3/42 (7.14%)  3
Alanine aminotransferase increased  27/46 (58.70%)  27 25/42 (59.52%)  25
Alkaline phosphatase increased  5/46 (10.87%)  5 3/42 (7.14%)  3
Aspartate aminotransferase increased  16/46 (34.78%)  16 21/42 (50.00%)  21
Blood bilirubin increased  1/46 (2.17%)  1 13/42 (30.95%)  13
CD4 lymphocytes decreased  1/46 (2.17%)  1 0/42 (0.00%)  0
Cholesterol high  0/46 (0.00%)  0 2/42 (4.76%)  2
Creatinine increased  6/46 (13.04%)  6 8/42 (19.05%)  8
Fibrinogen decreased  0/46 (0.00%)  0 1/42 (2.38%)  1
GGT increased  0/46 (0.00%)  0 8/42 (19.05%)  8
INR increased  1/46 (2.17%)  1 1/42 (2.38%)  1
Investigations - Other, specify  1/46 (2.17%)  1 5/42 (11.90%)  5
Lipase increased  0/46 (0.00%)  0 1/42 (2.38%)  1
Lymphocyte count decreased  9/46 (19.57%)  9 9/42 (21.43%)  9
Neutrophil count decreased  31/46 (67.39%)  31 35/42 (83.33%)  35
Platelet count decreased  29/46 (63.04%)  29 34/42 (80.95%)  34
Serum amylase increased  0/46 (0.00%)  0 3/42 (7.14%)  3
Weight gain  0/46 (0.00%)  0 1/42 (2.38%)  1
Weight loss  3/46 (6.52%)  3 6/42 (14.29%)  6
White blood cell decreased  31/46 (67.39%)  31 29/42 (69.05%)  29
Metabolism and nutrition disorders     
Acidosis  0/46 (0.00%)  0 1/42 (2.38%)  1
Alkalosis  1/46 (2.17%)  1 2/42 (4.76%)  2
Anorexia  3/46 (6.52%)  3 12/42 (28.57%)  12
Dehydration  3/46 (6.52%)  3 5/42 (11.90%)  5
Hypercalcemia  2/46 (4.35%)  2 5/42 (11.90%)  5
Hyperglycemia  20/46 (43.48%)  20 18/42 (42.86%)  18
Hyperkalemia  1/46 (2.17%)  1 3/42 (7.14%)  3
Hypermagnesemia  4/46 (8.70%)  4 1/42 (2.38%)  1
Hypernatremia  1/46 (2.17%)  1 4/42 (9.52%)  4
Hypertriglyceridemia  2/46 (4.35%)  2 3/42 (7.14%)  3
Hyperuricemia  1/46 (2.17%)  1 3/42 (7.14%)  3
Hypoalbuminemia  13/46 (28.26%)  13 18/42 (42.86%)  18
Hypocalcemia  16/46 (34.78%)  16 20/42 (47.62%)  20
Hypoglycemia  1/46 (2.17%)  1 3/42 (7.14%)  3
Hypokalemia  17/46 (36.96%)  17 23/42 (54.76%)  23
Hypomagnesemia  10/46 (21.74%)  10 9/42 (21.43%)  9
Hyponatremia  16/46 (34.78%)  16 16/42 (38.10%)  16
Hypophosphatemia  14/46 (30.43%)  14 11/42 (26.19%)  11
Tumor lysis syndrome  2/46 (4.35%)  2 4/42 (9.52%)  4
Musculoskeletal and connective tissue disorders     
Arthralgia  0/46 (0.00%)  0 2/42 (4.76%)  2
Back pain  5/46 (10.87%)  5 5/42 (11.90%)  5
Bone pain  1/46 (2.17%)  1 3/42 (7.14%)  3
Buttock pain  1/46 (2.17%)  1 0/42 (0.00%)  0
Myalgia  2/46 (4.35%)  2 0/42 (0.00%)  0
Neck pain  1/46 (2.17%)  1 2/42 (4.76%)  2
Pain in extremity  2/46 (4.35%)  2 5/42 (11.90%)  5
Nervous system disorders     
Abducens nerve disorder  0/46 (0.00%)  0 1/42 (2.38%)  1
Cognitive disturbance  0/46 (0.00%)  0 1/42 (2.38%)  1
Dizziness  2/46 (4.35%)  2 3/42 (7.14%)  3
Dysgeusia  1/46 (2.17%)  1 0/42 (0.00%)  0
Extrapyramidal disorder  1/46 (2.17%)  1 0/42 (0.00%)  0
Facial nerve disorder  0/46 (0.00%)  0 1/42 (2.38%)  1
Headache  9/46 (19.57%)  9 8/42 (19.05%)  8
Nervous system disorders - Other, specify  0/46 (0.00%)  0 1/42 (2.38%)  1
Neuralgia  0/46 (0.00%)  0 2/42 (4.76%)  2
Peripheral motor neuropathy  0/46 (0.00%)  0 2/42 (4.76%)  2
Peripheral sensory neuropathy  3/46 (6.52%)  3 2/42 (4.76%)  2
Seizure  0/46 (0.00%)  0 2/42 (4.76%)  2
Tremor  0/46 (0.00%)  0 1/42 (2.38%)  1
Trigeminal nerve disorder  0/46 (0.00%)  0 1/42 (2.38%)  1
Psychiatric disorders     
Agitation  0/46 (0.00%)  0 2/42 (4.76%)  2
Anxiety  3/46 (6.52%)  3 2/42 (4.76%)  2
Confusion  1/46 (2.17%)  1 1/42 (2.38%)  1
Depression  2/46 (4.35%)  2 1/42 (2.38%)  1
Insomnia  2/46 (4.35%)  2 0/42 (0.00%)  0
Psychosis  0/46 (0.00%)  0 1/42 (2.38%)  1
Renal and urinary disorders     
Acute kidney injury  1/46 (2.17%)  1 1/42 (2.38%)  1
Bladder spasm  0/46 (0.00%)  0 1/42 (2.38%)  1
Cystitis noninfective  0/46 (0.00%)  0 1/42 (2.38%)  1
Proteinuria  0/46 (0.00%)  0 1/42 (2.38%)  1
Renal and urinary disorders - Other, specify  1/46 (2.17%)  1 0/42 (0.00%)  0
Urinary frequency  0/46 (0.00%)  0 1/42 (2.38%)  1
Urinary tract obstruction  1/46 (2.17%)  1 1/42 (2.38%)  1
Urinary tract pain  3/46 (6.52%)  3 2/42 (4.76%)  2
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  0/46 (0.00%)  0 1/42 (2.38%)  1
Bronchopulmonary hemorrhage  0/46 (0.00%)  0 1/42 (2.38%)  1
Bronchospasm  0/46 (0.00%)  0 1/42 (2.38%)  1
Cough  1/46 (2.17%)  1 4/42 (9.52%)  4
Dyspnea  0/46 (0.00%)  0 2/42 (4.76%)  2
Epistaxis  1/46 (2.17%)  1 2/42 (4.76%)  2
Hypoxia  2/46 (4.35%)  2 5/42 (11.90%)  5
Pharyngeal mucositis  2/46 (4.35%)  2 3/42 (7.14%)  3
Pharyngolaryngeal pain  4/46 (8.70%)  4 1/42 (2.38%)  1
Pleural effusion  1/46 (2.17%)  1 2/42 (4.76%)  2
Pneumonitis  0/46 (0.00%)  0 1/42 (2.38%)  1
Respiratory, thoracic and mediastinal disorders - Other, specify  0/46 (0.00%)  0 2/42 (4.76%)  2
Skin and subcutaneous tissue disorders     
Alopecia  2/46 (4.35%)  2 1/42 (2.38%)  1
Body odor  0/46 (0.00%)  0 1/42 (2.38%)  1
Erythema multiforme  0/46 (0.00%)  0 1/42 (2.38%)  1
Hyperhidrosis  0/46 (0.00%)  0 2/42 (4.76%)  2
Nail loss  0/46 (0.00%)  0 1/42 (2.38%)  1
Pain of skin  0/46 (0.00%)  0 1/42 (2.38%)  1
Pruritus  3/46 (6.52%)  3 4/42 (9.52%)  4
Purpura  0/46 (0.00%)  0 3/42 (7.14%)  3
Rash acneiform  1/46 (2.17%)  1 1/42 (2.38%)  1
Rash maculo-papular  4/46 (8.70%)  4 12/42 (28.57%)  12
Skin and subcutaneous tissue disorders - Other, specify  1/46 (2.17%)  1 4/42 (9.52%)  4
Skin hyperpigmentation  1/46 (2.17%)  1 0/42 (0.00%)  0
Skin ulceration  0/46 (0.00%)  0 2/42 (4.76%)  2
Stevens-Johnson syndrome  0/46 (0.00%)  0 1/42 (2.38%)  1
Urticaria  0/46 (0.00%)  0 1/42 (2.38%)  1
Vascular disorders     
Flushing  0/46 (0.00%)  0 1/42 (2.38%)  1
Hypertension  5/46 (10.87%)  5 10/42 (23.81%)  10
Hypotension  2/46 (4.35%)  2 9/42 (21.43%)  9
Thromboembolic event  1/46 (2.17%)  1 1/42 (2.38%)  1
Vascular disorders - Other, specify  1/46 (2.17%)  1 0/42 (0.00%)  0
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
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: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00057811     History of Changes
Other Study ID Numbers: ANHL01P1
NCI-2009-00405 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ANHL01P1 ( Other Identifier: Children's Oncology Group )
CDR0000271941 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: April 7, 2003
First Posted: April 9, 2003
Results First Submitted: January 21, 2014
Results First Posted: August 22, 2014
Last Update Posted: September 19, 2014