Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058370
Status:
COMPLETED
Last Update Posted:
2020-05-11
First Post:
2003-04-07
Brief Title:
Intrathecal Radioimmunotherapy Radiation Therapy and Chemotherapy After Surgery in Treating Patients With Medulloblastoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Trial Of Radioimmunotherapy Reduced-Dose External Beam Craniospinal Radiation Therapy With IMRT Boost And Chemotherapy For Patients With Standard-Risk Medulloblastoma
Status:
COMPLETED
Status Verified Date:
2019-06
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 Radioimmunotherapy uses radiolabeled monoclonal antibodies to locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining intrathecal radioimmunotherapy and radiation therapy with combination chemotherapy may kill any tumor cells remaining after surgery
PURPOSE Phase II trial to study the effectiveness of combining intrathecal radioimmunotherapy and radiation therapy with combination chemotherapy in treating patients who have undergone surgery for medulloblastoma
PURPOSE Phase II trial to study the effectiveness of combining intrathecal radioimmunotherapy and radiation therapy with combination chemotherapy in treating patients who have undergone surgery for medulloblastoma
Detailed Description:
OBJECTIVES
Determine the feasibility of combining post-operative intrathecal radioimmunotherapy craniospinal radiotherapy with intensity-modulated radiotherapy boost and chemotherapy in patients with standard-risk medulloblastoma
Determine whether this regimen can maintain or exceed the current progression-free survival rate while decreasing long-term serious morbidity in these patients
Determine the long-term morbidities most specifically neuropsychological neuroendocrine audiometric and growth outcomes in patients treated with this regimen
OUTLINE
Radioimmunotherapy Patients receive intrathecal iodine I 131 monoclonal antibody 3F8 on days 1 and 8
Radiotherapy Beginning as soon as possible after radioimmunotherapy patients undergo external-beam and intensity-modulated radiotherapy 5 days a week for 6 weeks
Chemotherapy Patients receive vincristine IV once weekly for 8 weeks concurrently with radiotherapy Beginning about 6 weeks after completion of radiotherapy 4 weeks after vincristine patients receive cisplatin IV over 6 hours and oral lomustine on day 0 and vincristine IV on days 0 7 and 14 Treatment repeats every 6 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 6-20 patients will be accrued for this study within 32 years
Determine the feasibility of combining post-operative intrathecal radioimmunotherapy craniospinal radiotherapy with intensity-modulated radiotherapy boost and chemotherapy in patients with standard-risk medulloblastoma
Determine whether this regimen can maintain or exceed the current progression-free survival rate while decreasing long-term serious morbidity in these patients
Determine the long-term morbidities most specifically neuropsychological neuroendocrine audiometric and growth outcomes in patients treated with this regimen
OUTLINE
Radioimmunotherapy Patients receive intrathecal iodine I 131 monoclonal antibody 3F8 on days 1 and 8
Radiotherapy Beginning as soon as possible after radioimmunotherapy patients undergo external-beam and intensity-modulated radiotherapy 5 days a week for 6 weeks
Chemotherapy Patients receive vincristine IV once weekly for 8 weeks concurrently with radiotherapy Beginning about 6 weeks after completion of radiotherapy 4 weeks after vincristine patients receive cisplatin IV over 6 hours and oral lomustine on day 0 and vincristine IV on days 0 7 and 14 Treatment repeats every 6 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 6-20 patients will be accrued for this study within 32 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 |
|---|---|---|---|
| MSKCC-02088 | None | None | None |