Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025077
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2001-10-11
Brief Title:
Combination Chemotherapy Surgery or Radiation Therapy and Peripheral Stem Cell Transplant in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment Of Recurrent Central Nervous System Primitive Neuroectodermal Tumors PNETs In Children And Adolescents A Strategy Including The Use Of High Dose Thiotepa And High Dose Carboplatin
Status:
COMPLETED
Status Verified Date:
2007-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Giving a chemotherapy drug before surgery or radiation therapy may shrink the tumor so that it can be removed during surgery or radiation therapy Peripheral stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy and allow doctors to give higher doses of chemotherapy
PURPOSE This phase II trial is studying how well combination chemotherapy followed by surgery or radiation therapy and peripheral stem cell transplant work in treating patients with recurrent medulloblastoma or primitive neuroectodermal and pineal tumors
PURPOSE This phase II trial is studying how well combination chemotherapy followed by surgery or radiation therapy and peripheral stem cell transplant work in treating patients with recurrent medulloblastoma or primitive neuroectodermal and pineal tumors
Detailed Description:
OBJECTIVES
Determine the feasibility of cyclophosphamide and surgical resection or radiotherapy followed by thiotepa carboplatin and autologous peripheral blood stem cell rescue in patients with recurrent medulloblastoma or supratentorial neuroectodermal and pineal tumors
Determine the acute and chronic toxicity of this regimen in these patients
Determine progression-free and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Cytoreductive Phase Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and filgrastim G-CSF subcutaneously SC once daily beginning on day 7 and continuing until blood counts recover Treatment repeats after discontinuation of G-CSF for 2-4 courses Peripheral blood stem cells PBSC are harvested after each course of cyclophosphamide Patients undergo surgical resection or radiotherapy after the completion of chemotherapy Patients achieving complete response proceed to myeloablative therapy
Myeloablative Phase Patients receive thiotepa IV over 3 hours on days 1-3 Autologous PBSC are reinfused on day 5 and patients receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover Beginning 2 days after the completion of G-CSF patients receive carboplatin IV over 1 hour on days 1-3 Autologous PBSC are reinfused on day 5 and patients receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover
Patients are followed at 1 3 6 and 12 months
PROJECTED ACCRUAL Approximately 50 patients will be accrued for this study within 5 years
Determine the feasibility of cyclophosphamide and surgical resection or radiotherapy followed by thiotepa carboplatin and autologous peripheral blood stem cell rescue in patients with recurrent medulloblastoma or supratentorial neuroectodermal and pineal tumors
Determine the acute and chronic toxicity of this regimen in these patients
Determine progression-free and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Cytoreductive Phase Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and filgrastim G-CSF subcutaneously SC once daily beginning on day 7 and continuing until blood counts recover Treatment repeats after discontinuation of G-CSF for 2-4 courses Peripheral blood stem cells PBSC are harvested after each course of cyclophosphamide Patients undergo surgical resection or radiotherapy after the completion of chemotherapy Patients achieving complete response proceed to myeloablative therapy
Myeloablative Phase Patients receive thiotepa IV over 3 hours on days 1-3 Autologous PBSC are reinfused on day 5 and patients receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover Beginning 2 days after the completion of G-CSF patients receive carboplatin IV over 1 hour on days 1-3 Autologous PBSC are reinfused on day 5 and patients receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover
Patients are followed at 1 3 6 and 12 months
PROJECTED ACCRUAL Approximately 50 patients will be accrued for this study within 5 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20105 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068910 | REGISTRY | None | None |