Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033293
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2002-04-09
Brief Title:
Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone
Status:
COMPLETED
Status Verified Date:
2023-01
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:
This randomized phase III trial is studying cyclophosphamide prednisone and immunoglobulin to see how well they work compared to cyclophosphamide and prednisone alone in treating patients with abnormal trunk muscle movements associated with neuroblastoma Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die Steroid therapy decreases inflammation Combining chemotherapy and steroid therapy with immunoglobulin may be effective in treating abnormal muscle movement associated with neuroblastoma
Detailed Description:
PRIMARY OBJECTIVES
I Determine whether cyclophosphamide and prednisone with or without immune globulin is a reasonable baseline standard therapy for pediatric patients with neuroblastoma-associated opsoclonus-myoclonus-ataxia OMA syndrome
II Determine whether immunosuppressive therapy with cyclophosphamide and prednisone is an effective backbone therapy for OMA upon which to build additional treatment for these patients
SECONDARY OBJECTIVES
I Determine whether these regimens improve OMA syndrome in these patients II Determine whether these regimens improve motor coordination in these patients
III Determine these regimens improve functional outcome in these patients IV Investigate the biology of neuroblastoma associated OMA with specific regard to magnetic resonance imaging MRI findings anti-neuronal antibodies cerebrospinal fluid CSF findings and tumor biology
VI Define better the long-term prognosis for neurologic recovery in the child with neuroblastoma associated with OMA syndrome VII Compare the event-free and overall survival of patients treated with these regimens
OUTLINE
CHEMOTHERAPY Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy including cyclophosphamide according to the standard of care for the stage of primary neuroblastoma beginning on day 0 Patients with low-risk neuroblastoma and not receiving other chemotherapy receive cyclophosphamide IV over 1 hour on day 0 Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months
IMMUNE GLOBULIN THERAPY Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive immune globulin IV on days -2 and -1 at weeks 4 8 12 16 20 and 24 and then at months 8 10 and 12 after therapy Treatment continues in the absence of disease progression or unacceptable toxicity Patients with no response after 6 months go off treatment
ARM II Patients do not receive immune globulin Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I
Patients are followed during therapy every month for 6 months at 1 year and then annually for up to 10 years
I Determine whether cyclophosphamide and prednisone with or without immune globulin is a reasonable baseline standard therapy for pediatric patients with neuroblastoma-associated opsoclonus-myoclonus-ataxia OMA syndrome
II Determine whether immunosuppressive therapy with cyclophosphamide and prednisone is an effective backbone therapy for OMA upon which to build additional treatment for these patients
SECONDARY OBJECTIVES
I Determine whether these regimens improve OMA syndrome in these patients II Determine whether these regimens improve motor coordination in these patients
III Determine these regimens improve functional outcome in these patients IV Investigate the biology of neuroblastoma associated OMA with specific regard to magnetic resonance imaging MRI findings anti-neuronal antibodies cerebrospinal fluid CSF findings and tumor biology
VI Define better the long-term prognosis for neurologic recovery in the child with neuroblastoma associated with OMA syndrome VII Compare the event-free and overall survival of patients treated with these regimens
OUTLINE
CHEMOTHERAPY Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy including cyclophosphamide according to the standard of care for the stage of primary neuroblastoma beginning on day 0 Patients with low-risk neuroblastoma and not receiving other chemotherapy receive cyclophosphamide IV over 1 hour on day 0 Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months
IMMUNE GLOBULIN THERAPY Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive immune globulin IV on days -2 and -1 at weeks 4 8 12 16 20 and 24 and then at months 8 10 and 12 after therapy Treatment continues in the absence of disease progression or unacceptable toxicity Patients with no response after 6 months go off treatment
ARM II Patients do not receive immune globulin Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I
Patients are followed during therapy every month for 6 months at 1 year and then annually for up to 10 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-2009-00399 | REGISTRY | None | None |
| COG-ANBL00P3 | None | None | None |
| CDR0000069271 | None | None | None |
| ANBL00P3 | OTHER | None | None |
| ANBL00P3 | OTHER | None | None |
| U10CA013539 | NIH | None | None |
| U10CA180886 | NIH | None | None |
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |