Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002463
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Children With Astrocytomas and Primitive Neuroectodermal Tumors
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Methotrexate Mechlorethamine Vincristine Prednisone and Procarbazine MMOPP as Primary Therapy in Infants or Young Children With Primitive Neuroectodermal Tumors or High-Grade Astrocytoma
Status:
COMPLETED
Status Verified Date:
2013-02
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of methotrexate mechlorethamine vincristine procarbazine and prednisone in treating children with astrocytomas or primitive neuroectodermal tumors
PURPOSE Phase II trial to study the effectiveness of methotrexate mechlorethamine vincristine procarbazine and prednisone in treating children with astrocytomas or primitive neuroectodermal tumors
Detailed Description:
OBJECTIVES I Determine the efficacy of high-dose methotrexate HMTX in combination with mechlorethamine vincristine prednisone and procarbazine MOPP in infants or young children with primitive neuroectodermal tumors PNET including medulloblastoma anaplastic ependymoma ependymoblastoma or pineoblastoma or high-grade astrocytoma II Determine whether the addition of HMTX to MOPP MMOPP improves the continuous complete response rate of MOPP alone and eliminates the need for salvage with radiotherapy in these patients III Determine the ability of MMOPP to provide neuroaxis prophylaxis or to treat spinal metastasis without radiotherapy in infants or young children with PNET IV Determine the toxicity of this regimen in terms of neurologic and neuropsychologic sequelae growth and development in these patients V Correlate the efficacy of this regimen with the histopathologic diagnosis of these patients VI Determine the optimum method for radiographic evaluation of spinal cord disease in patients with PNET VII Determine the utility of sequential spinal cord radiography as a means of monitoring PNET in these patients
OUTLINE Patients undergo maximum tumor debulking Patients who have undergone incomplete resection proceed to induction Patients with a primary diagnosis of primitive neuroectodermal and pineal tumors or glioblastoma multiforme who have undergone total resection proceed to induction Induction Patients receive high dose methotrexate HMTX IV over 6 hours on day 1 Beginning 3 hours after completion of HMTX infusion leucovorin calcium CF is administered IV over 30 minutes every 3 hours for 9 doses Beginning 3 hours after completion of the last CF infusion oral CF is administered every 6 hours for 8 doses Patients receive a second HMTX infusion beginning 1 week after completion of the first HMTX infusion Beginning 1 week after completion of the second HMTX infusion patients receive mechlorethamine IV and vincristine IV on days 1 and 8 oral procarbazine and oral prednisone on days 1-10 and tapered doses of prednisone on days 11-13 MOPP Maintenance Beginning 4 weeks after initiating the first course of MOPP patients receive HMTX on day 1 and MOPP beginning on day 4 Treatment continues every 31 days in the absence of disease progression or unacceptable toxicity After 1 year or 14 doses of HMTX whichever occurs first HMTX is discontinued and treatment with MOPP alone continues every 4 weeks in the absence of disease progression or unacceptable toxicity Treatment is discontinued after 2 years if the patient is in continuous complete remission
PROJECTED ACCRUAL A total of 5-25 patients will be accrued for this study within 24-30 months
OUTLINE Patients undergo maximum tumor debulking Patients who have undergone incomplete resection proceed to induction Patients with a primary diagnosis of primitive neuroectodermal and pineal tumors or glioblastoma multiforme who have undergone total resection proceed to induction Induction Patients receive high dose methotrexate HMTX IV over 6 hours on day 1 Beginning 3 hours after completion of HMTX infusion leucovorin calcium CF is administered IV over 30 minutes every 3 hours for 9 doses Beginning 3 hours after completion of the last CF infusion oral CF is administered every 6 hours for 8 doses Patients receive a second HMTX infusion beginning 1 week after completion of the first HMTX infusion Beginning 1 week after completion of the second HMTX infusion patients receive mechlorethamine IV and vincristine IV on days 1 and 8 oral procarbazine and oral prednisone on days 1-10 and tapered doses of prednisone on days 11-13 MOPP Maintenance Beginning 4 weeks after initiating the first course of MOPP patients receive HMTX on day 1 and MOPP beginning on day 4 Treatment continues every 31 days in the absence of disease progression or unacceptable toxicity After 1 year or 14 doses of HMTX whichever occurs first HMTX is discontinued and treatment with MOPP alone continues every 4 weeks in the absence of disease progression or unacceptable toxicity Treatment is discontinued after 2 years if the patient is in continuous complete remission
PROJECTED ACCRUAL A total of 5-25 patients will be accrued for this study within 24-30 months
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 |
|---|---|---|---|
| CDR0000075917 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-P-88006 | None | None | None |
| NCI-V89-0125 | None | None | None |