Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392327
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-26
First Post:
2006-10-25
Brief Title:
Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Previously Untreated High-Risk MedulloblastomaPNET
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk MedulloblastomaPNET Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed previously untreated high-risk medulloblastoma Chemotherapy drugs such as vincristine sulfate cisplatin cyclophosphamide and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Giving more than one drug combination chemotherapy may kill more tumor cells Radiation therapy uses high-energy x-rays particles or radioactive seeds to kill tumor cells and shrink tumors Carboplatin may make tumor cells more sensitive to radiation therapy It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether carboplatin radiosensitization increases long term event-free survival for high risk medulloblastomaprimitive neuroectodermal tumor PNET patients
II To determine whether isotretinoin increases long term event-free survival for high risk medulloblastomaPNET patients
CORRELATIVE SCIENCE OBJECTIVES
I To compare residual disease response to radiation alone versus radiation plus carboplatin
II To identify molecular prognostic indicators suitable for patient stratification in future trials
III To evaluate the health-related quality of life HRQOL during phases of active treatment specific to treatment modalities
IV To describe the neuropsychological functioning of the study population and to evaluate the relationship between neuropsychological status and health related quality of life
OUTLINE Patients are randomized to Arm A or Arm B Arms C and D closed to accrual as of Amendment 3 12715
ARM A standard chemoradiotherapy and standard maintenance therapy
CHEMORADIOTHERAPY Patients undergo radiation therapy once daily QD five days a week for 6 weeks Patients also receive vincristine sulfate intravenously IV over 1 minute once weekly for 6 weeks Six weeks after completion of chemoradiotherapy patients proceed to maintenance therapy
MAINTENANCE THERAPY Patients receive cisplatin IV over 6 hours on day 1 vincristine sulfate IV over 1 minute on days 1 and 8 and cyclophosphamide IV over 1 hour on days 2 and 3 Patients also receive filgrastim subcutaneously SC or IV beginning on day 4 and continuing until blood counts recover at least 10 days Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients also undergo blood sample collection lumbar puncture and magnetic resonance imaging MRI throughout the study
ARM B standard chemoradiotherapy plus carboplatin and standard maintenance therapy
CHEMORADIOTHERAPY Patients receive vincristine sulfate and undergo radiation therapy as in Arm I Patients also receive carboplatin IV over 15 minutes on each day of radiation therapy Six weeks after completion of chemoradiotherapy patients proceed to maintenance therapy
MAINTENANCE THERAPY Patients receive maintenance therapy as in Arm I
Patients also undergo blood sample collection lumbar puncture and MRI throughout the study
ARM C standard chemoradiotherapy standard maintenance therapy plus isotretinoin and continuation therapy with isotretinoin - CLOSED TO ACCRUAL 12715
CHEMORADIOTHERAPY Patients undergo chemoradiotherapy as in Arm I Six weeks after completion of chemoradiotherapy patients proceed to maintenance therapy
MAINTENANCE THERAPY Patients receive isotretinoin orally PO twice daily BID on day 1 and days 16-28 and cisplatin vincristine sulfate cyclophosphamide and filgrastim as in Arm I maintenance therapy Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity Patients then proceed to continuation therapy
CONTINUATION THERAPY Patients receive isotretinoin PO BID on days 15-28 every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
ARM D standard chemoradiotherapy plus carboplatin standard maintenance therapy plus isotretinoin and continuation therapy with isotretinoin - CLOSED TO ACCRUAL 12715
CHEMORADIOTHERAPY Patients undergo chemoradiotherapy as in Arm II Six weeks after completion of chemoradiotherapy patients proceed to maintenance therapy
MAINTENANCE THERAPY Patients receive maintenance therapy as in Arm III Patients then proceed to continuation therapy
CONTINUATION THERAPY Patients receive continuation therapy as in Arm III
After completion of study treatment patients are followed up periodically for 1 year
I To determine whether carboplatin radiosensitization increases long term event-free survival for high risk medulloblastomaprimitive neuroectodermal tumor PNET patients
II To determine whether isotretinoin increases long term event-free survival for high risk medulloblastomaPNET patients
CORRELATIVE SCIENCE OBJECTIVES
I To compare residual disease response to radiation alone versus radiation plus carboplatin
II To identify molecular prognostic indicators suitable for patient stratification in future trials
III To evaluate the health-related quality of life HRQOL during phases of active treatment specific to treatment modalities
IV To describe the neuropsychological functioning of the study population and to evaluate the relationship between neuropsychological status and health related quality of life
OUTLINE Patients are randomized to Arm A or Arm B Arms C and D closed to accrual as of Amendment 3 12715
ARM A standard chemoradiotherapy and standard maintenance therapy
CHEMORADIOTHERAPY Patients undergo radiation therapy once daily QD five days a week for 6 weeks Patients also receive vincristine sulfate intravenously IV over 1 minute once weekly for 6 weeks Six weeks after completion of chemoradiotherapy patients proceed to maintenance therapy
MAINTENANCE THERAPY Patients receive cisplatin IV over 6 hours on day 1 vincristine sulfate IV over 1 minute on days 1 and 8 and cyclophosphamide IV over 1 hour on days 2 and 3 Patients also receive filgrastim subcutaneously SC or IV beginning on day 4 and continuing until blood counts recover at least 10 days Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients also undergo blood sample collection lumbar puncture and magnetic resonance imaging MRI throughout the study
ARM B standard chemoradiotherapy plus carboplatin and standard maintenance therapy
CHEMORADIOTHERAPY Patients receive vincristine sulfate and undergo radiation therapy as in Arm I Patients also receive carboplatin IV over 15 minutes on each day of radiation therapy Six weeks after completion of chemoradiotherapy patients proceed to maintenance therapy
MAINTENANCE THERAPY Patients receive maintenance therapy as in Arm I
Patients also undergo blood sample collection lumbar puncture and MRI throughout the study
ARM C standard chemoradiotherapy standard maintenance therapy plus isotretinoin and continuation therapy with isotretinoin - CLOSED TO ACCRUAL 12715
CHEMORADIOTHERAPY Patients undergo chemoradiotherapy as in Arm I Six weeks after completion of chemoradiotherapy patients proceed to maintenance therapy
MAINTENANCE THERAPY Patients receive isotretinoin orally PO twice daily BID on day 1 and days 16-28 and cisplatin vincristine sulfate cyclophosphamide and filgrastim as in Arm I maintenance therapy Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity Patients then proceed to continuation therapy
CONTINUATION THERAPY Patients receive isotretinoin PO BID on days 15-28 every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
ARM D standard chemoradiotherapy plus carboplatin standard maintenance therapy plus isotretinoin and continuation therapy with isotretinoin - CLOSED TO ACCRUAL 12715
CHEMORADIOTHERAPY Patients undergo chemoradiotherapy as in Arm II Six weeks after completion of chemoradiotherapy patients proceed to maintenance therapy
MAINTENANCE THERAPY Patients receive maintenance therapy as in Arm III Patients then proceed to continuation therapy
CONTINUATION THERAPY Patients receive continuation therapy as in Arm III
After completion of study treatment patients are followed up periodically for 1 year
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-2009-00336 | REGISTRY | None | None |
| 07-271 | None | None | None |
| CDR0000511991 | None | None | None |
| COG-ACNS0332 | None | None | None |
| ACNS0332 | OTHER | None | None |
| ACNS0332 | OTHER | None | None |
| R01CA114567 | NIH | None | None |
| U10CA180886 | NIH | None | None |
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |