Ignite Creation Date:
2024-05-05 @ 11:26 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01334515
Status:
COMPLETED
Last Update Posted:
2019-10-21
First Post:
2011-04-12
Brief Title:
Biological Therapy Sargramostim and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
FeasibilityPhase II Study of hu1418-IL2 Immunocytokine GM-CSF and Isotretinoin in Patients With Relapsed or Refractory Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2019-10
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:
This phase II trial is studying how well hu1418-interleukin-2 IL2 fusion protein works when given together with sargramostim and isotretinoin in treating patients with relapsed or refractory neuroblastoma Biological therapy such as hu1418-IL2 fusion protein and sargramostim work in different ways to stimulate the immune system and stop tumor cells from growing Drugs used in chemotherapy such as isotretinoin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving hu1418-IL2 fusion protein together with sargramostim and isotretinoin may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the safety and tolerability of sargramostim GM-CSF and isotretinoin given in combination with hu1418-IL-2 hu1418-IL2 fusion protein as a test of feasibility for a future Phase III study
II To evaluate the anti-tumor activity of hu1418-IL2 given in combination with GM-CSF and isotretinoin in patients with recurrent or refractory neuroblastoma with disease measurable by standard radiographic criteria stratum-1
III To evaluate the anti-tumor activity of hu1418-IL2 given in combination with GM-CSF and isotretinoin in patients with recurrent or refractory neuroblastoma evaluable only by meta iodo benzyl guanidine I 123 MIBG scintigraphy andor bone marrow histology stratum-2
SECONDARY OBJECTIVES
I To describe the disease burden of stratum-2 patients by semi-quantitative assessment of bone marrow and MIBG scintigraphy and determine whether there is an association between lower disease burden and response to hu1418-IL2
II To assess molecular parameters of response reverse-transcriptase RT polymerase chain reaction PCR for patients meeting complete response CR criteria
III To evaluate the immunologic activation induced in vivo by hu1418-IL2 IV To determine the induction of anti-hu1418-IL2 antibody by treatment with hu1418-IL2
V To test for associations between tumor response versus immune activation and anti-hu1418-IL2 activity and between measurements of toxicity versus immune activation and anti-hu1418-IL2 activity
OUTLINE This is a multicenter study Patients are stratified according to measurable disease disease measurable by standard radiographic criteria stratum-1 vs disease evaluable only by meta iodo benzyl guanidine I 123 MIBG andor bone marrow histology stratum-2
Patients receive sargramostim subcutaneously SC preferred or IV over 2 hours on days 1-2 and 8-14 hu1418-IL2 fusion protein IV over 4 hours on days 4-6 and isotretinoin orally PO twice daily on days 11-24 Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity Patients in stratum-1 who achieve stable disease SD after course 4 are removed from protocol therapy Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment Patients may undergo blood and bone marrow sample collection periodically for correlative studies
After completion of study therapy patients are followed up every 3 months for 1 year every 6 months for 2 years and then yearly for 2 years
I To evaluate the safety and tolerability of sargramostim GM-CSF and isotretinoin given in combination with hu1418-IL-2 hu1418-IL2 fusion protein as a test of feasibility for a future Phase III study
II To evaluate the anti-tumor activity of hu1418-IL2 given in combination with GM-CSF and isotretinoin in patients with recurrent or refractory neuroblastoma with disease measurable by standard radiographic criteria stratum-1
III To evaluate the anti-tumor activity of hu1418-IL2 given in combination with GM-CSF and isotretinoin in patients with recurrent or refractory neuroblastoma evaluable only by meta iodo benzyl guanidine I 123 MIBG scintigraphy andor bone marrow histology stratum-2
SECONDARY OBJECTIVES
I To describe the disease burden of stratum-2 patients by semi-quantitative assessment of bone marrow and MIBG scintigraphy and determine whether there is an association between lower disease burden and response to hu1418-IL2
II To assess molecular parameters of response reverse-transcriptase RT polymerase chain reaction PCR for patients meeting complete response CR criteria
III To evaluate the immunologic activation induced in vivo by hu1418-IL2 IV To determine the induction of anti-hu1418-IL2 antibody by treatment with hu1418-IL2
V To test for associations between tumor response versus immune activation and anti-hu1418-IL2 activity and between measurements of toxicity versus immune activation and anti-hu1418-IL2 activity
OUTLINE This is a multicenter study Patients are stratified according to measurable disease disease measurable by standard radiographic criteria stratum-1 vs disease evaluable only by meta iodo benzyl guanidine I 123 MIBG andor bone marrow histology stratum-2
Patients receive sargramostim subcutaneously SC preferred or IV over 2 hours on days 1-2 and 8-14 hu1418-IL2 fusion protein IV over 4 hours on days 4-6 and isotretinoin orally PO twice daily on days 11-24 Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity Patients in stratum-1 who achieve stable disease SD after course 4 are removed from protocol therapy Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment Patients may undergo blood and bone marrow sample collection periodically for correlative studies
After completion of study therapy patients are followed up every 3 months for 1 year every 6 months for 2 years and then yearly for 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-2011-02672 | REGISTRY | None | None |
| CDR0000698589 | OTHER | None | None |
| U10CA098543 | NIH | None | None |
| COG-ANBL1021 | OTHER | Childrens Oncology Group | httpsreporternihgovquickSearchU10CA098543 |