Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003273
Status:
WITHDRAWN
Last Update Posted:
2015-12-03
First Post:
1999-11-01
Brief Title:
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Dose Intensive Chemotherapy for Children Less Than Ten Years of Age Newly-Diagnosed With Malignant Brain Tumors A Pilot Study of Two Alternative Intensive Induction Chemotherapy Regimens Followed by Consolidation With Myeloablative Chemotherapy Thiotepa Etoposide and Carboplatin and Autologous Stem Cell Rescue
Status:
WITHDRAWN
Status Verified Date:
2015-11
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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of different regimens of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have newly diagnosed brain tumor
PURPOSE Phase II trial to study the effectiveness of different regimens of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have newly diagnosed brain tumor
Detailed Description:
OBJECTIVES
Investigate the toxicity of and response rate to an intensification of an induction chemotherapy regimen regimen A cisplatin vincristine cyclophosphamide and etoposide by incorporation of high-dose methotrexate with leucovorin calcium rescue in patients with primitive neuroectodermal tumors and evidence of leptomeningeal dissemination M1 M2 or M3
Investigate the toxicity of and response rate to a new dose intensive induction chemotherapy regimen regimen C vincristine carboplatin and temozolomide in children under ten years of age who are newly diagnosed with either high grade gliomas or diffuse intrinsic pontine tumors Regimen B closed to accrual effective 3302000 regimen C open to accrual effective 7212000
Investigate the feasibility of utilizing regimen C chemotherapy followed by consolidation with myeloablative chemotherapy and autologous stem cell either bone marrow andor peripheral blood rescue in these patients Regimen B closed to accrual effective 3302000 regimen C open to accrual effective 7212000
Investigate the toxicity of and response rate to an intensification of induction regimen A chemotherapy by incorporation of high-dose methotrexate with leucovorin calcium rescue in patients with primitive neuroectodermal tumors and evidence of leptomeningeal dissemination M1 M2 or M3
Estimate the time to disease progression and the pattern of relapse in patients who do not have radiographic or cytologic evidence of residual disease at the time of consolidation chemotherapy and who therefore do not receive post consolidation irradiation
Estimate the time to disease progression and the pattern of relapse in patients who have radiographic or cytologic evidence of residual disease at the time of consolidation chemotherapy and who therefore receive post consolidation irradiation
Assess the morbidity and mortality of the consolidation chemotherapy regimen following either regimen C or the intensified regimen A in these patients Regimen B closed to accrual effective 3302000 regimen C open to accrual effective 7212000
Assess the impact that irradiation avoidance or the administration of reduced volume craniospinal andor focused field local irradiation has on neuropsychometric endocrinological functions and physical growth
OUTLINE This is a two regimen study based on disease characteristics
Patients in regimens A B and C undergo leukapheresis after receiving filgrastim G-CSF by subcutaneous SC injections
Regimen A Patients without evidence of neuraxis dissemination receive five 21 day courses of the following chemotherapy cisplatin IV over 6 hours on day 0 etoposide and cyclophosphamide IV over 1 hour on days 1 and 2 vincristine IV on days 0 7 and 14 of courses 1 2 and 3 and G-CSF SC beginning on day 3 of each course and continuing until blood counts recover or up to 48 hours before the start of the next course Patients with evidence of neuraxis dissemination also receive high-dose methotrexate IV over 4 hours on day 3 and leucovorin calcium orally or by IV bolus starting 24 hours prior to methotrexate and continuing every 6 hours until methotrexate levels have diminished
Regimen B closed to accrual effective 3302000 Patients receive three 21-28 day courses of the following chemotherapy vincristine IV on days 0 7 and 14 of each course carboplatin IV over 4 hours on days 3 and 4 of each course oral procarbazine daily on days 0-4 oral lomustine on days 3 and 4 and G-CSF SC daily beginning 24 hours following the last dose of carboplatin and continuing until blood counts recover or up to 48 hours before the start of the next course On day 7 of each course patients also receive peripheral blood stem cell PBSC reinfusion following chemotherapy Oral lomustine is administered only for the first two courses
Regimen C open to accrual effective 07212000 Patients receive four 28 day courses of the following chemotherapy carboplatin IV over 4 hours on days 0 and 1 of each course vincristine IV on days 0 7 and 14 of the first three courses only oral temozolomide daily on days 0-4 and G-CSF SC daily beginning on day 5 and continuing until blood counts recover
After regimen A B or C and in the absence of disease progression patients undergo consolidation myeloablative chemotherapy by receiving carboplatin IV over 4 hours on days -8 -7 and -6 and then thiotepa IV over 3 hours followed by etoposide IV on days -5 -4 and -3 Patients with malignant gliomas or unbiopsied diffuse intrinsic pontine tumors do not receive etoposide On day 0 patients are reinfused with autologous PBSC Following recovery from consolidation chemotherapy patients with radiographic or cytologic evidence of residual disease undergo radiotherapy
Patients are followed at 3 months then every 3 months for the first 2 years then every 6 months for years 2-4 and then annually thereafter
PROJECTED ACCRUAL Approximately 96 patients 73 for regimen A and 23 for regimen C will be accrued for this study Regimen B closed to accrual effective 3302000
Investigate the toxicity of and response rate to an intensification of an induction chemotherapy regimen regimen A cisplatin vincristine cyclophosphamide and etoposide by incorporation of high-dose methotrexate with leucovorin calcium rescue in patients with primitive neuroectodermal tumors and evidence of leptomeningeal dissemination M1 M2 or M3
Investigate the toxicity of and response rate to a new dose intensive induction chemotherapy regimen regimen C vincristine carboplatin and temozolomide in children under ten years of age who are newly diagnosed with either high grade gliomas or diffuse intrinsic pontine tumors Regimen B closed to accrual effective 3302000 regimen C open to accrual effective 7212000
Investigate the feasibility of utilizing regimen C chemotherapy followed by consolidation with myeloablative chemotherapy and autologous stem cell either bone marrow andor peripheral blood rescue in these patients Regimen B closed to accrual effective 3302000 regimen C open to accrual effective 7212000
Investigate the toxicity of and response rate to an intensification of induction regimen A chemotherapy by incorporation of high-dose methotrexate with leucovorin calcium rescue in patients with primitive neuroectodermal tumors and evidence of leptomeningeal dissemination M1 M2 or M3
Estimate the time to disease progression and the pattern of relapse in patients who do not have radiographic or cytologic evidence of residual disease at the time of consolidation chemotherapy and who therefore do not receive post consolidation irradiation
Estimate the time to disease progression and the pattern of relapse in patients who have radiographic or cytologic evidence of residual disease at the time of consolidation chemotherapy and who therefore receive post consolidation irradiation
Assess the morbidity and mortality of the consolidation chemotherapy regimen following either regimen C or the intensified regimen A in these patients Regimen B closed to accrual effective 3302000 regimen C open to accrual effective 7212000
Assess the impact that irradiation avoidance or the administration of reduced volume craniospinal andor focused field local irradiation has on neuropsychometric endocrinological functions and physical growth
OUTLINE This is a two regimen study based on disease characteristics
Patients in regimens A B and C undergo leukapheresis after receiving filgrastim G-CSF by subcutaneous SC injections
Regimen A Patients without evidence of neuraxis dissemination receive five 21 day courses of the following chemotherapy cisplatin IV over 6 hours on day 0 etoposide and cyclophosphamide IV over 1 hour on days 1 and 2 vincristine IV on days 0 7 and 14 of courses 1 2 and 3 and G-CSF SC beginning on day 3 of each course and continuing until blood counts recover or up to 48 hours before the start of the next course Patients with evidence of neuraxis dissemination also receive high-dose methotrexate IV over 4 hours on day 3 and leucovorin calcium orally or by IV bolus starting 24 hours prior to methotrexate and continuing every 6 hours until methotrexate levels have diminished
Regimen B closed to accrual effective 3302000 Patients receive three 21-28 day courses of the following chemotherapy vincristine IV on days 0 7 and 14 of each course carboplatin IV over 4 hours on days 3 and 4 of each course oral procarbazine daily on days 0-4 oral lomustine on days 3 and 4 and G-CSF SC daily beginning 24 hours following the last dose of carboplatin and continuing until blood counts recover or up to 48 hours before the start of the next course On day 7 of each course patients also receive peripheral blood stem cell PBSC reinfusion following chemotherapy Oral lomustine is administered only for the first two courses
Regimen C open to accrual effective 07212000 Patients receive four 28 day courses of the following chemotherapy carboplatin IV over 4 hours on days 0 and 1 of each course vincristine IV on days 0 7 and 14 of the first three courses only oral temozolomide daily on days 0-4 and G-CSF SC daily beginning on day 5 and continuing until blood counts recover
After regimen A B or C and in the absence of disease progression patients undergo consolidation myeloablative chemotherapy by receiving carboplatin IV over 4 hours on days -8 -7 and -6 and then thiotepa IV over 3 hours followed by etoposide IV on days -5 -4 and -3 Patients with malignant gliomas or unbiopsied diffuse intrinsic pontine tumors do not receive etoposide On day 0 patients are reinfused with autologous PBSC Following recovery from consolidation chemotherapy patients with radiographic or cytologic evidence of residual disease undergo radiotherapy
Patients are followed at 3 months then every 3 months for the first 2 years then every 6 months for years 2-4 and then annually thereafter
PROJECTED ACCRUAL Approximately 96 patients 73 for regimen A and 23 for regimen C will be accrued for this study Regimen B closed to accrual effective 3302000
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-V98-1400 | None | None | None |
| NYU-P9712 | None | None | None |