Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336024
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-25
First Post:
2006-06-08
Brief Title:
Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children lt 36 Months Old With Intensive Induction Chemotherapy With Methotrexate Followed by Consolidation With Stem Cell Rescue vs the Same Therapy Without Methotrexate
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 two different combination chemotherapy regimens to compare how well they work in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma when given before additional intense chemotherapy followed by peripheral blood stem cell rescue It is not yet known which combination chemotherapy regimen is more effective when given before a peripheral stem cell transplant in treating supratentorial primitive neuroectodermal tumors or medulloblastoma
Detailed Description:
PRIMARY OBJECTIVES
I To determine if treatment of infants with high risk primitive neuroectodermal tumors PNET central nervous system CNS tumors with intensive chemotherapy plus high-dose methotrexate and peripheral blood stem cell rescue results in a higher complete response rate then the same regimen without methotrexate
SECONDARY OBJECTIVES
I To determine whether biologic characterization of these tumors will refine therapeutic stratification separating atypical teratoid rhabdoid tumors ATRT from primitive neuroectodermal tumors PNETs and possibly identifying other markers of value for stratification within the group of PNETs
II To determine if event free survival EFS and patterns of failure differ between the methotrexate arm versus the arm without methotrexate
III To compare the acute chronic and late effects of these two very intensive regimens especially as to the tolerance of the same consolidation regimen following the differing induction regimens
IV To compare the gastrointestinal and nutritional toxicities of these intense regimens
V To describe and compare the quality of life outcomes and neuropsychological effects of these intense systemic therapies
OUTLINE Patients are randomized to 1 of 2 treatment arms
INDUCTION THERAPY
ARM I Patients receive vincristine IV over 1 minute on days 1 8 and 15 etoposide IV over 1 hour on days 1-3 cyclophosphamide IV over 1 hour on days 1 and 2 cisplatin IV over 6 hours on day 3 and filgrastim G-CSF IV or subcutaneously SC beginning on day 4 and continuing until blood counts recover Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive vincristine IV over 1 minute on days 1 8 and 15 high-dose methotrexate IV over 4 hours on day 1 and leucovorin calcium IV or orally PO every 6 hours beginning on day 2 and continuing until methotrexate levels are in a safe range Once methotrexate levels are in a safe range patients then receive etoposide IV over 1 hour on approximately days 4 5 and 6 cyclophosphamide IV over 1 hour on approximately days 4 and 5 and cisplatin IV over 6 hours on approximately day 6 Patients also receive G-CSF IV or SC beginning 24 hours after the completion of chemotherapy and continuing until blood counts recover Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
In both arms patients with stable disease or partial response after induction therapy proceed to second-look surgery followed by consolidation therapy Patients with a complete response after induction therapy proceed directly to consolidation therapy
CONSOLIDATION THERAPY Beginning no more than 6 weeks after completion of induction therapy patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and G-CSF IV or SC beginning on day 5 and continuing until blood counts recover Patients also receive autologous peripheral blood stem cells PBSC IV on day 4 Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed up periodically for 4 years and then annually thereafter
I To determine if treatment of infants with high risk primitive neuroectodermal tumors PNET central nervous system CNS tumors with intensive chemotherapy plus high-dose methotrexate and peripheral blood stem cell rescue results in a higher complete response rate then the same regimen without methotrexate
SECONDARY OBJECTIVES
I To determine whether biologic characterization of these tumors will refine therapeutic stratification separating atypical teratoid rhabdoid tumors ATRT from primitive neuroectodermal tumors PNETs and possibly identifying other markers of value for stratification within the group of PNETs
II To determine if event free survival EFS and patterns of failure differ between the methotrexate arm versus the arm without methotrexate
III To compare the acute chronic and late effects of these two very intensive regimens especially as to the tolerance of the same consolidation regimen following the differing induction regimens
IV To compare the gastrointestinal and nutritional toxicities of these intense regimens
V To describe and compare the quality of life outcomes and neuropsychological effects of these intense systemic therapies
OUTLINE Patients are randomized to 1 of 2 treatment arms
INDUCTION THERAPY
ARM I Patients receive vincristine IV over 1 minute on days 1 8 and 15 etoposide IV over 1 hour on days 1-3 cyclophosphamide IV over 1 hour on days 1 and 2 cisplatin IV over 6 hours on day 3 and filgrastim G-CSF IV or subcutaneously SC beginning on day 4 and continuing until blood counts recover Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive vincristine IV over 1 minute on days 1 8 and 15 high-dose methotrexate IV over 4 hours on day 1 and leucovorin calcium IV or orally PO every 6 hours beginning on day 2 and continuing until methotrexate levels are in a safe range Once methotrexate levels are in a safe range patients then receive etoposide IV over 1 hour on approximately days 4 5 and 6 cyclophosphamide IV over 1 hour on approximately days 4 and 5 and cisplatin IV over 6 hours on approximately day 6 Patients also receive G-CSF IV or SC beginning 24 hours after the completion of chemotherapy and continuing until blood counts recover Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
In both arms patients with stable disease or partial response after induction therapy proceed to second-look surgery followed by consolidation therapy Patients with a complete response after induction therapy proceed directly to consolidation therapy
CONSOLIDATION THERAPY Beginning no more than 6 weeks after completion of induction therapy patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and G-CSF IV or SC beginning on day 5 and continuing until blood counts recover Patients also receive autologous peripheral blood stem cells PBSC IV on day 4 Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed up periodically for 4 years and then annually thereafter
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-2009-00338 | REGISTRY | None | None |
| CDR0000483683 | None | None | None |
| 07-654 | None | None | None |
| ACNS0334 | None | None | None |
| COG-ACNS0334 | None | None | None |
| ACNS0334 | OTHER | None | None |
| ACNS0334 | OTHER | None | None |
| U10CA180886 | NIH | None | None |
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |