Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082758
Status:
COMPLETED
Last Update Posted:
2015-02-12
First Post:
2004-05-14
Brief Title:
hu1418-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Study Of hu1418-IL2 In Children With Recurrent Or Refractory Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Biological therapies such as hu1418-interleukin-2 fusion protein work in different ways to stimulate the immune system and stop tumor cells from growing
PURPOSE This phase II trial is studying how well hu1418-interleukin-2 fusion protein works in treating young patients with recurrent or refractory neuroblastoma
PURPOSE This phase II trial is studying how well hu1418-interleukin-2 fusion protein works in treating young patients with recurrent or refractory neuroblastoma
Detailed Description:
OBJECTIVES
Determine the response rate in children with recurrent or refractory neuroblastoma treated with hu1418-interleukin-2 hu1418-IL2 fusion protein
Determine the adverse events of this drug in these patients
Determine the immunologic activation in patients treated with this drug
Determine the induction of anti-hu1418-IL2 antibody in patients treated with this drug
Correlate antitumor response with measurements of toxicity immune activation and anti-hu1418-IL2 antibody activity in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to measurableevaluable disease measurable by standard radiographic criteria vs evaluable by MIBG meta-iodobenzylguanidine scanning andor bone marrow histology vs disease identified and quantified by bone marrow immunohistochemistry
For standard radiographic criteria this study will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors RECIST from the National Cancer Institute Complete Response CR - Disappearance of all target lesions No evidence of tumor at any site chest abdomen liver bone bone marrow nodes etc Very Good Partial Response VGPR - Greater than 90 decrease of the disease measurement for CTMRI target lesions taking as reference the disease measurement done to confirm measurable disease in target lesions at study entry all pre-existing bone lesions with CR by MIBG MIBG scan can be SD or CR in soft tissue lesions corresponding to lesions on CTMRI Partial Response PR - At least a 30 decrease in the disease measurement for CTMRI target lesions taking as reference the disease measurement done to confirm measurable disease in target lesions at study entry Progressive Disease PD - Any one of the following a At least a 20 increase in the disease measurement for CTMRI target lesions taking as reference the smallest disease measurement recorded since the start of treatment b Appearance of one or more new lesions or new sites of tumor c PD as defined above for either bone marrow or MIBG lesions
Stable disease SD - The patient will be classified as stable disease for overall response if there is stable disease by either CTMRI lesion bone marrow or MIBG criteria No new lesions no new sites of disease
Patients will be enrolled in 3 strata and evaluated for antitumor response following 2 monthly courses treatment on Days 1-3 followed by 25 days of observation Patients with progressive disease will be taken off protocol therapy Patients with stabilization or regression of disease will be eligible to receive 2 more monthly courses of treatment Additional treatment following course 4 will be allowed for patients showing a continued clinical response up to a maximum of 10 courses of treatment
Patients are followed for survival
PROJECTED ACCRUAL A total of 40-60 patients 20 for strata 1 and 2 and 0-20 for stratum 3 will be accrued for this study within 2 years
Determine the response rate in children with recurrent or refractory neuroblastoma treated with hu1418-interleukin-2 hu1418-IL2 fusion protein
Determine the adverse events of this drug in these patients
Determine the immunologic activation in patients treated with this drug
Determine the induction of anti-hu1418-IL2 antibody in patients treated with this drug
Correlate antitumor response with measurements of toxicity immune activation and anti-hu1418-IL2 antibody activity in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to measurableevaluable disease measurable by standard radiographic criteria vs evaluable by MIBG meta-iodobenzylguanidine scanning andor bone marrow histology vs disease identified and quantified by bone marrow immunohistochemistry
For standard radiographic criteria this study will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors RECIST from the National Cancer Institute Complete Response CR - Disappearance of all target lesions No evidence of tumor at any site chest abdomen liver bone bone marrow nodes etc Very Good Partial Response VGPR - Greater than 90 decrease of the disease measurement for CTMRI target lesions taking as reference the disease measurement done to confirm measurable disease in target lesions at study entry all pre-existing bone lesions with CR by MIBG MIBG scan can be SD or CR in soft tissue lesions corresponding to lesions on CTMRI Partial Response PR - At least a 30 decrease in the disease measurement for CTMRI target lesions taking as reference the disease measurement done to confirm measurable disease in target lesions at study entry Progressive Disease PD - Any one of the following a At least a 20 increase in the disease measurement for CTMRI target lesions taking as reference the smallest disease measurement recorded since the start of treatment b Appearance of one or more new lesions or new sites of tumor c PD as defined above for either bone marrow or MIBG lesions
Stable disease SD - The patient will be classified as stable disease for overall response if there is stable disease by either CTMRI lesion bone marrow or MIBG criteria No new lesions no new sites of disease
Patients will be enrolled in 3 strata and evaluated for antitumor response following 2 monthly courses treatment on Days 1-3 followed by 25 days of observation Patients with progressive disease will be taken off protocol therapy Patients with stabilization or regression of disease will be eligible to receive 2 more monthly courses of treatment Additional treatment following course 4 will be allowed for patients showing a continued clinical response up to a maximum of 10 courses of treatment
Patients are followed for survival
PROJECTED ACCRUAL A total of 40-60 patients 20 for strata 1 and 2 and 0-20 for stratum 3 will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-02583 | OTHER | NCI | None |
| CDR0000360723 | OTHER | None | None |
| COG-ANBL0322 | OTHER | None | None |