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hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma

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ClinicalTrials.gov Identifier: NCT00082758
Recruitment Status : Completed
First Posted : May 19, 2004
Results First Posted : January 16, 2014
Last Update Posted : February 12, 2015
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
Condition Neuroblastoma
Intervention Biological: hu14.18-Interleukin-2 fusion protein
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Disease Measurable by Standard Criteria(hu14.18-interleukin-2) Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2) Disease Identified by BM Immunohistochemistry Only
Hide Arm/Group Description

Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.

hu14.18-Interleukin-2 fusion protein : Given IV

Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by meta-iodobenzylguanidine (MIBG) scanning and/or by bone marrow (BM) histology.

hu14.18-Interleukin-2 fusion protein : Given IV

Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by meta-iodobenzylguanidine (MIBG) scanning or bone marrow (BM) histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells)

hu14.18-Interleukin-2 fusion protein : Given IV

Period Title: Overall Study
Started 15 24 0
Completed 0 7 0
Not Completed 15 17 0
Reason Not Completed
Adverse Event             0             2             0
Lack of Efficacy             12             13             0
Physician Decision             0             1             0
Withdrawal by Subject             3             0             0
Protocol Violation             0             1             0
Arm/Group Title Disease Measurable by Standard Criteria(hu14.18-interleukin-2) Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2) Disease Identified by BM Immunohistochemistry Only Total
Hide Arm/Group Description

Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.

hu14.18-Interleukin-2 fusion protein : Given IV

Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology.

hu14.18-Interleukin-2 fusion protein : Given IV

Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells).

hu14.18-Interleukin-2 fusion protein : Given IV

Total of all reporting groups
Overall Number of Baseline Participants 15 24 0 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 24 participants 0 participants 39 participants
<=18 years 15 23 38
Between 18 and 65 years 0 1 1
>=65 years 0 0 0
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 15 participants 24 participants 0 participants 39 participants
5.98
(4.74 to 10.89)
6.28
(5.32 to 9.09)
6.16
(4.78 to 9.40)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 24 participants 0 participants 39 participants
Female 7 10 17
Male 8 14 22
Ethnicity (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 24 participants 0 participants 39 participants
Hispanic or Latino 0 2 2
Not Hispanic or Latino 15 21 36
Unknown or Not Reported 0 1 1
Race (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 24 participants 0 participants 39 participants
American Indian or Alaska Native 0 1 1
Asian 0 1 1
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 5 3 8
White 9 18 27
More than one race 0 0 0
Unknown or Not Reported 1 1 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 24 participants 0 participants 39 participants
United States 14 22 36
Canada 1 2 3
1.Primary Outcome
Title Number of Responders (Response Rate)
Hide Description Response rate to hu14.18-Interleukin-2 in 3 separate strata of patients with recurrent or refractory neuroblastoma. Patients will have radiologic (CT/MRI) tumor and urine homovanillic acid (HVA)/vanillylmandelic acid (VMA) measurements. Patients with prior marrow involvement will have marrow assessments. Patients with MIBG+ (iodine-131-meta-iodobenzylguanidine) prior disease will have MIBG scans performed. For CT/MRI lesions, measureable disease is measured by the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. RECIST (v1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions.
Time Frame Up to 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients were evaluable for inclusion in the analysis of response if eligible, had an event (relapse, PD, death or secondary malignancy) any time after enrollment, or completed at least 2 courses of Irinotecan/Temozolomide therapy. Patients off therapy before completion of 2 courses by choice or toxicity were not evaluable for response analysis.
Arm/Group Title Disease Measurable by Standard Criteria(hu14.18-interleukin-2) Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2) Disease Identified by BM Immunohistochemistry Only
Hide Arm/Group Description:

Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.

hu14.18-Interleukin-2 fusion protein : Given IV

Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (meta-iodobenzylguanidine) scanning and/or by bone marrow histology.

hu14.18-Interleukin-2 fusion protein : Given IV

Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells)

hu14.18-Interleukin-2 fusion protein : Given IV

Overall Number of Participants Analyzed 13 23 0
Measure Type: Number
Unit of Measure: participants
Responder 0 5
Non-responder 13 18
Time Frame Duration of protocol therapy
Adverse Event Reporting Description Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) 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 Disease Measurable by Standard Criteria(hu14.18-interleukin-2) Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2) Disease Identified by BM Immunohistochemistry Only
Hide Arm/Group Description

Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.

hu14.18-Interleukin-2 fusion protein : Given IV

Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology.

hu14.18-Interleukin-2 fusion protein : Given IV

Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells).

hu14.18-Interleukin-2 fusion protein : Given IV

All-Cause Mortality
Disease Measurable by Standard Criteria(hu14.18-interleukin-2) Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2) Disease Identified by BM Immunohistochemistry Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Disease Measurable by Standard Criteria(hu14.18-interleukin-2) Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2) Disease Identified by BM Immunohistochemistry Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/15 (86.67%)      21/24 (87.50%)      0/0    
Blood and lymphatic system disorders       
Anemia  3/15 (20.00%)  4 6/24 (25.00%)  10 0/0 
Febrile neutropenia  0/15 (0.00%)  0 1/24 (4.17%)  2 0/0 
Ear and labyrinth disorders       
Hearing impaired  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Gastrointestinal disorders       
Abdominal pain  0/15 (0.00%)  0 1/24 (4.17%)  1 0/0 
General disorders       
Death NOS  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Immune system disorders       
Anaphylaxis  1/15 (6.67%)  1 3/24 (12.50%)  4 0/0 
Infections and infestations       
Bone infection  0/15 (0.00%)  0 1/24 (4.17%)  1 0/0 
Catheter related infection  1/15 (6.67%)  1 4/24 (16.67%)  9 0/0 
Infections and infestations  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Lung infection  0/15 (0.00%)  0 1/24 (4.17%)  1 0/0 
Tooth infection  0/15 (0.00%)  0 1/24 (4.17%)  1 0/0 
Investigations       
Alanine aminotransferase  4/15 (26.67%)  5 4/24 (16.67%)  6 0/0 
Aspartate aminotransferase  4/15 (26.67%)  5 5/24 (20.83%)  7 0/0 
Blood bilirubin increased  2/15 (13.33%)  3 6/24 (25.00%)  8 0/0 
GGT increased  0/15 (0.00%)  0 1/24 (4.17%)  1 0/0 
Lymphocyte count decrease  4/15 (26.67%)  8 11/24 (45.83%)  33 0/0 
Neutrophil count decreased  5/15 (33.33%)  5 8/24 (33.33%)  20 0/0 
Platelet count decreased  5/15 (33.33%)  6 11/24 (45.83%)  27 0/0 
White blood cell decrease  2/15 (13.33%)  3 7/24 (29.17%)  12 0/0 
Metabolism and nutrition disorders       
Anorexia  0/15 (0.00%)  0 1/24 (4.17%)  2 0/0 
Dehydration  0/15 (0.00%)  0 1/24 (4.17%)  1 0/0 
Hyperglycemia  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Hypoalbuminemia  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Hypokalemia  1/15 (6.67%)  1 3/24 (12.50%)  4 0/0 
Hyponatremia  1/15 (6.67%)  1 1/24 (4.17%)  1 0/0 
Hypophosphatemia  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Nervous system disorders       
Dizziness  0/15 (0.00%)  0 1/24 (4.17%)  1 0/0 
Psychiatric disorders       
Agitation  0/15 (0.00%)  0 1/24 (4.17%)  1 0/0 
Reproductive system and breast disorders       
Pelvic pain  0/15 (0.00%)  0 1/24 (4.17%)  1 0/0 
Respiratory, thoracic and mediastinal disorders       
Cough  0/15 (0.00%)  0 1/24 (4.17%)  1 0/0 
Dyspnea  0/15 (0.00%)  0 1/24 (4.17%)  1 0/0 
Pleural effusion  1/15 (6.67%)  1 1/24 (4.17%)  1 0/0 
Pneumonitis  0/15 (0.00%)  0 2/24 (8.33%)  2 0/0 
Skin and subcutaneous tissue disorders       
Pruritus  0/15 (0.00%)  0 1/24 (4.17%)  1 0/0 
Vascular disorders       
Hypotension  0/15 (0.00%)  0 1/24 (4.17%)  1 0/0 
1
Term from vocabulary, CTCv4
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Disease Measurable by Standard Criteria(hu14.18-interleukin-2) Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2) Disease Identified by BM Immunohistochemistry Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/15 (86.67%)      18/24 (75.00%)      0    
Blood and lymphatic system disorders       
Anemia  11/15 (73.33%)  23 14/24 (58.33%)  42 0/0 
Cardiac disorders       
Cardiac disorders - Other  0/15 (0.00%)  0 2/24 (8.33%)  2 0/0 
Sinus tachycardia  1/15 (6.67%)  1 7/24 (29.17%)  16 0/0 
Ear and labyrinth disorders       
Middle ear inflammation  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Gastrointestinal disorders       
Abdominal pain  2/15 (13.33%)  2 0/24 (0.00%)  0 0/0 
Ascites  2/15 (13.33%)  2 0/24 (0.00%)  0 0/0 
Constipation  0/15 (0.00%)  0 3/24 (12.50%)  4 0/0 
Diarrhea  1/15 (6.67%)  2 6/24 (25.00%)  10 0/0 
Nausea  2/15 (13.33%)  2 0/24 (0.00%)  0 0/0 
Vomiting  2/15 (13.33%)  3 8/24 (33.33%)  18 0/0 
General disorders       
Chills  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Edema face  3/15 (20.00%)  3 9/24 (37.50%)  17 0/0 
Edema limbs  3/15 (20.00%)  5 2/24 (8.33%)  5 0/0 
Edema trunk  1/15 (6.67%)  1 3/24 (12.50%)  4 0/0 
Fever  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Localized edema  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Infections and infestations       
Otitis media  0/15 (0.00%)  0 2/24 (8.33%)  2 0/0 
Pharyngitis  0/15 (0.00%)  0 2/24 (8.33%)  2 0/0 
Sinusitis  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Upper respiratory infection  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Injury, poisoning and procedural complications       
Bruising  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Investigations       
Alanine aminotransferase  10/15 (66.67%)  20 14/24 (58.33%)  41 0/0 
Alkaline phosphatase increased  2/15 (13.33%)  2 5/24 (20.83%)  7 0/0 
Aspartate aminotransferase  9/15 (60.00%)  17 15/24 (62.50%)  44 0/0 
Blood bilirubin increased  9/15 (60.00%)  13 9/24 (37.50%)  22 0/0 
Cholesterol high  1/15 (6.67%)  2 0/24 (0.00%)  0 0/0 
Creatinine increased  3/15 (20.00%)  6 4/24 (16.67%)  6 0/0 
GGT increased  1/15 (6.67%)  2 4/24 (16.67%)  9 0/0 
Investigations - Other  0/15 (0.00%)  0 2/24 (8.33%)  26 0/0 
Lymphocyte count decrease  1/15 (6.67%)  1 4/24 (16.67%)  8 0/0 
Neutrophil count decreased  5/15 (33.33%)  6 6/24 (25.00%)  14 0/0 
Platelet count decreased  8/15 (53.33%)  17 11/24 (45.83%)  22 0/0 
Weight gain  3/15 (20.00%)  3 6/24 (25.00%)  12 0/0 
White blood cell decrease  9/15 (60.00%)  16 10/24 (41.67%)  32 0/0 
Metabolism and nutrition disorders       
Acidosis  2/15 (13.33%)  2 3/24 (12.50%)  4 0/0 
Anorexia  4/15 (26.67%)  4 3/24 (12.50%)  8 0/0 
Dehydration  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Hypercalcemia  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Hyperglycemia  7/15 (46.67%)  13 13/24 (54.17%)  26 0/0 
Hyperkalemia  1/15 (6.67%)  1 2/24 (8.33%)  2 0/0 
Hypermagnesemia  0/15 (0.00%)  0 3/24 (12.50%)  4 0/0 
Hypernatremia  1/15 (6.67%)  1 2/24 (8.33%)  2 0/0 
Hypertriglyceridemia  1/15 (6.67%)  2 0/24 (0.00%)  0 0/0 
Hypoalbuminemia  10/15 (66.67%)  20 15/24 (62.50%)  45 0/0 
Hypocalcemia  8/15 (53.33%)  17 14/24 (58.33%)  38 0/0 
Hypoglycemia  0/15 (0.00%)  0 3/24 (12.50%)  8 0/0 
Hypokalemia  4/15 (26.67%)  5 7/24 (29.17%)  17 0/0 
Hypomagnesemia  6/15 (40.00%)  14 8/24 (33.33%)  13 0/0 
Hyponatremia  4/15 (26.67%)  11 11/24 (45.83%)  27 0/0 
Hypophosphatemia  8/15 (53.33%)  14 11/24 (45.83%)  20 0/0 
Musculoskeletal and connective tissue disorders       
Bone pain  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Pain in extremity  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Nervous system disorders       
Intracranial hemorrhage  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Psychiatric disorders       
Anxiety  0/15 (0.00%)  0 2/24 (8.33%)  3 0/0 
Renal and urinary disorders       
Renal and urinary disorders, Other  0/15 (0.00%)  0 3/24 (12.50%)  3 0/0 
Urinary retention  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis  0/15 (0.00%)  0 2/24 (8.33%)  2 0/0 
Cough  4/15 (26.67%)  5 3/24 (12.50%)  7 0/0 
Dyspnea  1/15 (6.67%)  1 2/24 (8.33%)  3 0/0 
Epistaxis  1/15 (6.67%)  1 5/24 (20.83%)  5 0/0 
Pharyngolaryngeal pain  0/15 (0.00%)  0 2/24 (8.33%)  2 0/0 
Pleural effusion  1/15 (6.67%)  1 3/24 (12.50%)  5 0/0 
Respiratory, thoracic and mediastinal disorders, Other  0/15 (0.00%)  0 2/24 (8.33%)  3 0/0 
Voice alteration  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Skin and subcutaneous tissue disorders       
Alopecia  0/15 (0.00%)  0 2/24 (8.33%)  2 0/0 
Dry skin  1/15 (6.67%)  1 5/24 (20.83%)  12 0/0 
Pruritus  2/15 (13.33%)  4 6/24 (25.00%)  10 0/0 
Rash maculo-papular  1/15 (6.67%)  1 0/24 (0.00%)  0 0/0 
Vascular disorders       
Flushing  0/15 (0.00%)  0 2/24 (8.33%)  2 0/0 
Hypertension  1/15 (6.67%)  1 3/24 (12.50%)  3 0/0 
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
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: NCT00082758    
Other Study ID Numbers: ANBL0322
CDR0000360723 ( Other Identifier: Clinical Trials.gov )
COG-ANBL0322 ( Other Identifier: Children's Oncology Group )
NCI-2012-02583 ( Other Identifier: NCI )
First Submitted: May 14, 2004
First Posted: May 19, 2004
Results First Submitted: December 2, 2013
Results First Posted: January 16, 2014
Last Update Posted: February 12, 2015