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Trial record 27 of 881 for:    "Reticulum Cell Sarcoma"

Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00059839
Recruitment Status : Completed
First Posted : May 7, 2003
Results First Posted : October 8, 2013
Last Update Posted : September 22, 2014
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
Condition Lymphoma
Interventions Drug: doxorubicin hydrochloride
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: vinblastine sulfate
Drug: vincristine sulfate
Enrollment 129
Recruitment Details This is a multi-center, phase III, randomized trial for newly diagnosed children with advanced-stage anaplastic large cell lymphoma (ALCL). The study was activated on November 3, 2003 and the first date of enrollment was January 13, 2004.
Pre-assignment Details Randomization occurs at the time of enrollment with all participants receiving Standard Induction of Doxorubicin, Prednisone and Vincristine (APO) and are evaluated at week 6 for continuation therapy.
Arm/Group Title Standard (APO) With Vincristine (Arm I) Consolidation (Includes Vinblastine) (Arm II)
Hide Arm/Group Description In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity. In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 65 64
Completed 53 47
Not Completed 12 17
Reason Not Completed
Death             1             1
Lack of Efficacy             6             5
Lost to Follow-up             2             0
Physician Decision             1             2
Withdrawal by Subject             1             6
Ineligible             1             3
Arm/Group Title Standard (APO) With Vincristine (Arm I) Consolidation (Includes Vinblastine) (Arm II) Total
Hide Arm/Group Description In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity. In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 65 64 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 64 participants 129 participants
<=18 years
62
  95.4%
62
  96.9%
124
  96.1%
Between 18 and 65 years
3
   4.6%
2
   3.1%
5
   3.9%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 64 participants 129 participants
Female
24
  36.9%
27
  42.2%
51
  39.5%
Male
41
  63.1%
37
  57.8%
78
  60.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 64 participants 129 participants
Hispanic or Latino
10
  15.4%
8
  12.5%
18
  14.0%
Not Hispanic or Latino
52
  80.0%
55
  85.9%
107
  82.9%
Unknown or Not Reported
3
   4.6%
1
   1.6%
4
   3.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 64 participants 129 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   7.7%
3
   4.7%
8
   6.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  10.8%
12
  18.8%
19
  14.7%
White
47
  72.3%
42
  65.6%
89
  69.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
   9.2%
7
  10.9%
13
  10.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 64 participants 129 participants
United States 59 52 111
Canada 3 9 12
Australia 2 2 4
Switzerland 1 1 2
1.Primary Outcome
Title Event-free Survival (EFS)
Hide Description Percentage of EFS patients. This is measured as the time from study entry until disease progression, disease recurrence, occurrence of a second malignant neoplasm, or death from any cause. To measure Event Free Survival, repeated one-sided logrank tests will be performed The upper critical values are based on the one-sided alpha-spending functions of t2 (alpha=0.05) and the lower critical values are based on testing the alternative hypothesis at 0.005 level.
Time Frame From first enrollment up to 3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
64 patients from Arm I were analyzed for this outcome measure, one patient was deemed ineligible. 61 patients from Arm II were analyzed for this outcome measure, three patients were deemed ineligible.
Arm/Group Title Standard (APO) With Vincristine (Arm I) Consolidation (Includes Vinblastine) (Arm II)
Hide Arm/Group Description:
In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 64 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74
(61 to 84)
79
(65 to 87)
Time Frame [Not Specified]
Adverse Event Reporting Description 64 patients are included for Arm I adverse events as one patient was deemed ineligible. 61 patients are included for Arm II adverse events as three patients were deemed ineligible.
 
Arm/Group Title Standard (APO) With Vincristine (Arm I) Consolidation (Includes Vinblastine) (Arm II)
Hide Arm/Group Description In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity. In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Standard (APO) With Vincristine (Arm I) Consolidation (Includes Vinblastine) (Arm II)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Standard (APO) With Vincristine (Arm I) Consolidation (Includes Vinblastine) (Arm II)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/64 (3.13%)      4/61 (6.56%)    
Blood and lymphatic system disorders     
Anemia  0/64 (0.00%)  0 1/61 (1.64%)  1
"Blood and lymphatic system disorders - Other"  0/64 (0.00%)  0 1/61 (1.64%)  1
Disseminated intravascular coagulation  1/64 (1.56%)  1 0/61 (0.00%)  0
Febrile neutropenia  0/64 (0.00%)  0 1/61 (1.64%)  1
Cardiac disorders     
Cardiac arrest  1/64 (1.56%)  1 0/61 (0.00%)  0
"Cardiac disorders - Other"  1/64 (1.56%)  1 1/61 (1.64%)  1
Gastrointestinal disorders     
Vomiting  0/64 (0.00%)  0 1/61 (1.64%)  1
General disorders     
Death NOS  0/64 (0.00%)  0 1/61 (1.64%)  1
Hepatobiliary disorders     
Hepatic failure  1/64 (1.56%)  1 1/1 (100.00%)  1
Investigations     
Activated partial thromboplastin time prolonged  1/64 (1.56%)  1 1/61 (1.64%)  1
Aspartate aminotransferase increased  1/64 (1.56%)  1 1/61 (1.64%)  1
CPK increased  1/64 (1.56%)  1 0/61 (0.00%)  0
Metabolism and nutrition disorders     
Hypokalemia  0/64 (0.00%)  0 1/61 (1.64%)  1
Nervous system disorders     
"Nervous system disorders - Other"  0/64 (0.00%)  0 1/61 (1.64%)  1
Seizure  1/64 (1.56%)  1 1/61 (1.64%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary hypertension  0/64 (0.00%)  0 1/61 (1.64%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard (APO) With Vincristine (Arm I) Consolidation (Includes Vinblastine) (Arm II)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   47/64 (73.44%)      52/61 (85.25%)    
Blood and lymphatic system disorders     
Anemia  14/64 (21.88%)  14 24/61 (39.34%)  24
Disseminated intravascular coagulation  0/64 (0.00%)  0 1/61 (1.64%)  1
Febrile neutropenia  7/64 (10.94%)  7 18/61 (29.51%)  18
Cardiac disorders     
"Cardiac disorders - Other"  2/64 (3.13%)  2 0/61 (0.00%)  0
Conduction disorder  1/64 (1.56%)  1 0/61 (0.00%)  0
Sinus tachycardia  0/64 (0.00%)  0 3/61 (4.92%)  3
Ear and labyrinth disorders     
Middle ear inflammation  1/64 (1.56%)  1 0/61 (0.00%)  0
Eye disorders     
Blurred vision  0/64 (0.00%)  0 1/61 (1.64%)  1
Cataract  0/64 (0.00%)  0 1/61 (1.64%)  1
"Eye disorders - Other"  0/64 (0.00%)  0 1/61 (1.64%)  1
Gastrointestinal disorders     
Abdominal pain  4/64 (6.25%)  4 5/61 (8.20%)  5
Anal mucositis  0/64 (0.00%)  0 1/61 (1.64%)  1
Colonic perforation  0/64 (0.00%)  0 1/61 (1.64%)  1
Constipation  5/64 (7.81%)  5 8/61 (13.11%)  8
Diarrhea  0/64 (0.00%)  0 5/61 (8.20%)  5
Enterocolitis  0/64 (0.00%)  0 1/61 (1.64%)  1
Esophageal pain  0/64 (0.00%)  0 1/61 (1.64%)  1
Gastritis  0/64 (0.00%)  0 1/61 (1.64%)  1
"Gastrointestinal disorders - Other"  2/64 (3.13%)  2 1/61 (1.64%)  1
Gingival pain  0/64 (0.00%)  0 3/61 (4.92%)  3
Ileus  0/64 (0.00%)  0 1/61 (1.64%)  1
Mucositis oral  6/64 (9.38%)  6 7/61 (11.48%)  7
Nausea  3/64 (4.69%)  3 8/61 (13.11%)  8
Oral pain  1/64 (1.56%)  1 0/61 (0.00%)  0
Pancreatitis  0/64 (0.00%)  0 1/61 (1.64%)  1
Stomach pain  1/64 (1.56%)  1 2/61 (3.28%)  2
Typhlitis  0/64 (0.00%)  0 2/61 (3.28%)  2
Vomiting  1/64 (1.56%)  1 10/61 (16.39%)  10
General disorders     
Chills  0/64 (0.00%)  0 1/61 (1.64%)  1
Edema limbs  0/64 (0.00%)  0 3/61 (4.92%)  3
Fatigue  3/64 (4.69%)  3 5/61 (8.20%)  5
Fever  4/64 (6.25%)  4 6/61 (9.84%)  6
Injection site reaction  0/64 (0.00%)  0 1/61 (1.64%)  1
Irritability  0/64 (0.00%)  0 1/61 (1.64%)  1
Non-cardiac chest pain  0/64 (0.00%)  0 1/61 (1.64%)  1
Pain  3/64 (4.69%)  3 6/61 (9.84%)  6
Infections and infestations     
Catheter related infection  4/64 (6.25%)  4 1/61 (1.64%)  1
Gum infection  0/64 (0.00%)  0 1/61 (1.64%)  1
"Infections and infestations - Other"  6/64 (9.38%)  6 20/61 (32.79%)  20
Laryngitis  1/64 (1.56%)  1 0/61 (0.00%)  0
Lung infection  1/64 (1.56%)  1 0/61 (0.00%)  0
Mucosal infection  1/64 (1.56%)  1 0/61 (0.00%)  0
Otitis externa  1/64 (1.56%)  1 0/61 (0.00%)  0
Otitis media  0/64 (0.00%)  0 1/61 (1.64%)  1
Penile infection  0/64 (0.00%)  0 1/61 (1.64%)  1
Pharyngitis  1/64 (1.56%)  1 0/61 (0.00%)  0
Rhinitis infective  0/64 (0.00%)  0 1/61 (1.64%)  1
Sepsis  1/64 (1.56%)  1 0/61 (0.00%)  0
Skin infection  1/64 (1.56%)  1 1/61 (1.64%)  1
Upper respiratory infection  2/64 (3.13%)  2 2/61 (3.28%)  2
Urinary tract infection  2/64 (3.13%)  2 1/61 (1.64%)  1
Vaginal infection  0/64 (0.00%)  0 1/61 (1.64%)  1
Injury, poisoning and procedural complications     
Fracture  1/64 (1.56%)  1 1/61 (1.64%)  1
"Injury, poisoning and procedural complications - Other"  1/64 (1.56%)  1 0/61 (0.00%)  0
Vascular access complication  0/64 (0.00%)  0 1/61 (1.64%)  1
Investigations     
Activated partial thromboplastin time prolonged  0/64 (0.00%)  0 1/61 (1.64%)  1
Alanine aminotransferase increased  15/64 (23.44%)  15 26/61 (42.62%)  26
Aspartate aminotransferase increased  7/64 (10.94%)  7 16/61 (26.23%)  16
Blood bilirubin increased  2/64 (3.13%)  2 4/61 (6.56%)  4
Creatinine increased  1/64 (1.56%)  1 3/61 (4.92%)  3
GGT increased  3/64 (4.69%)  3 2/61 (3.28%)  2
INR increased  0/64 (0.00%)  0 1/61 (1.64%)  1
"Investigations - Other"  2/64 (3.13%)  2 0/61 (0.00%)  0
Lipase increased  1/64 (1.56%)  1 1/61 (1.64%)  1
Lymphocyte count decreased  2/64 (3.13%)  2 8/61 (13.11%)  8
Neutrophil count decreased  34/64 (53.13%)  34 47/61 (77.05%)  47
Platelet count decreased  6/64 (9.38%)  6 9/61 (14.75%)  9
Serum amylase increased  1/64 (1.56%)  1 1/61 (1.64%)  1
Weight gain  2/64 (3.13%)  2 2/61 (3.28%)  2
Weight loss  0/64 (0.00%)  0 3/61 (4.92%)  3
White blood cell decreased  20/64 (31.25%)  20 31/61 (50.82%)  31
Metabolism and nutrition disorders     
Acidosis  1/64 (1.56%)  1 0/61 (0.00%)  0
Anorexia  3/64 (4.69%)  3 1/61 (1.64%)  1
Dehydration  1/64 (1.56%)  1 2/61 (3.28%)  2
Hypercalcemia  0/64 (0.00%)  0 2/61 (3.28%)  2
Hyperglycemia  8/64 (12.50%)  8 9/61 (14.75%)  9
Hyperkalemia  0/64 (0.00%)  0 3/61 (4.92%)  3
Hypermagnesemia  2/64 (3.13%)  2 2/61 (3.28%)  2
Hypernatremia  0/64 (0.00%)  0 2/61 (3.28%)  2
Hyperuricemia  1/64 (1.56%)  1 0/61 (0.00%)  0
Hypoalbuminemia  3/64 (4.69%)  3 6/61 (9.84%)  6
Hypocalcemia  5/64 (7.81%)  5 12/61 (19.67%)  12
Hypoglycemia  1/64 (1.56%)  1 1/61 (1.64%)  1
Hypokalemia  7/64 (10.94%)  7 12/61 (19.67%)  12
Hypomagnesemia  1/64 (1.56%)  1 3/61 (4.92%)  3
Hyponatremia  4/64 (6.25%)  4 6/61 (9.84%)  6
Hypophosphatemia  4/64 (6.25%)  4 6/61 (9.84%)  6
Musculoskeletal and connective tissue disorders     
Arthralgia  1/64 (1.56%)  1 1/61 (1.64%)  1
Avascular necrosis  1/64 (1.56%)  1 0/61 (0.00%)  0
Back pain  2/64 (3.13%)  2 3/61 (4.92%)  3
Bone pain  2/64 (3.13%)  2 1/61 (1.64%)  1
Chest wall pain  0/64 (0.00%)  0 2/61 (3.28%)  2
Muscle weakness lower limb  0/64 (0.00%)  0 1/61 (1.64%)  1
Muscle weakness upper limb  1/64 (1.56%)  1 1/61 (1.64%)  1
"Musculoskeletal and connective tissue disorder - Other, specify"  0/64 (0.00%)  0 2/61 (3.28%)  2
Neck pain  1/64 (1.56%)  1 1/61 (1.64%)  1
Pain in extremity  2/64 (3.13%)  2 1/61 (1.64%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain  1/64 (1.56%)  1 0/61 (0.00%)  0
Nervous system disorders     
Cognitive disturbance  0/64 (0.00%)  0 1/61 (1.64%)  1
Depressed level of consciousness  0/64 (0.00%)  0 1/61 (1.64%)  1
Dizziness  0/64 (0.00%)  0 1/61 (1.64%)  1
Dysgeusia  0/64 (0.00%)  0 1/61 (1.64%)  1
Headache  2/64 (3.13%)  2 9/61 (14.75%)  9
Leukoencephalopathy  1/64 (1.56%)  1 0/61 (0.00%)  0
Neuralgia  0/64 (0.00%)  0 1/61 (1.64%)  1
Peripheral motor neuropathy  1/64 (1.56%)  1 6/61 (9.84%)  6
Peripheral sensory neuropathy  3/64 (4.69%)  3 7/61 (11.48%)  7
Seizure  1/64 (1.56%)  1 0/61 (0.00%)  0
Psychiatric disorders     
Agitation  1/64 (1.56%)  1 0/61 (0.00%)  0
Anxiety  0/64 (0.00%)  0 2/61 (3.28%)  2
Depression  0/64 (0.00%)  0 2/61 (3.28%)  2
Insomnia  0/64 (0.00%)  0 2/61 (3.28%)  2
Personality change  1/64 (1.56%)  1 2/61 (3.28%)  2
Renal and urinary disorders     
Acute kidney injury  0/64 (0.00%)  0 1/61 (1.64%)  1
Bladder spasm  1/64 (1.56%)  1 0/61 (0.00%)  0
Cystitis noninfective  0/64 (0.00%)  0 1/61 (1.64%)  1
Urinary frequency  1/64 (1.56%)  1 0/61 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1/64 (1.56%)  1 0/61 (0.00%)  0
Apnea  0/64 (0.00%)  0 1/61 (1.64%)  1
Bronchospasm  0/64 (0.00%)  0 1/61 (1.64%)  1
Cough  1/64 (1.56%)  1 2/61 (3.28%)  2
Dyspnea  0/64 (0.00%)  0 2/61 (3.28%)  2
Epistaxis  0/64 (0.00%)  0 1/61 (1.64%)  1
Hypoxia  0/64 (0.00%)  0 2/61 (3.28%)  2
Pharyngeal mucositis  0/64 (0.00%)  0 1/61 (1.64%)  1
Pharyngolaryngeal pain  0/64 (0.00%)  0 2/61 (3.28%)  2
Pleural effusion  0/64 (0.00%)  0 1/61 (1.64%)  1
Pneumonitis  0/64 (0.00%)  0 1/61 (1.64%)  1
"Respiratory, thoracic and mediastinal disorders - Other"  0/64 (0.00%)  0 1/61 (1.64%)  1
Skin and subcutaneous tissue disorders     
Alopecia  0/64 (0.00%)  0 1/61 (1.64%)  1
Hyperhidrosis  0/64 (0.00%)  0 2/61 (3.28%)  2
Pain of skin  0/64 (0.00%)  0 1/61 (1.64%)  1
Pruritus  1/64 (1.56%)  1 4/61 (6.56%)  4
Rash acneiform  0/64 (0.00%)  0 1/61 (1.64%)  1
Rash maculo-papular  1/64 (1.56%)  1 3/61 (4.92%)  3
"Skin and subcutaneous tissue disorders - Other"  0/64 (0.00%)  0 2/61 (3.28%)  2
Skin ulceration  0/64 (0.00%)  0 1/61 (1.64%)  1
Urticaria  0/64 (0.00%)  0 1/61 (1.64%)  1
Vascular disorders     
Hypertension  1/64 (1.56%)  1 6/61 (9.84%)  6
Hypotension  1/64 (1.56%)  1 4/61 (6.56%)  4
Thromboembolic event  0/64 (0.00%)  0 1/61 (1.64%)  1
Certain Agreements
Principal Investigators are NOT 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
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
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00059839     History of Changes
Other Study ID Numbers: ANHL0131
CDR0000298777 ( Other Identifier: Clinical Trials.gov )
COG-ANHL0131 ( Other Identifier: Children's Oncology Group )
First Submitted: May 6, 2003
First Posted: May 7, 2003
Results First Submitted: June 28, 2013
Results First Posted: October 8, 2013
Last Update Posted: September 22, 2014