Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017368
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2001-06-06
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Neuroblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Pilot Study Of Tandem High Dose Chemotherapy With Stem Cell Rescue Following Induction Therapy In Children With High Risk Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2014-02
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 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 combination chemotherapy followed by peripheral stem cell transplantation in treating children who have newly diagnosed neuroblastoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have newly diagnosed neuroblastoma
Detailed Description:
OBJECTIVES
Determine the toxicity and feasibility of high-dose thiotepa and cyclophosphamide with autologous peripheral blood stem cell PBSC transplantation and sargramostim GM-CSF followed by high-dose carboplatin etoposide and melphalan with second PBSC transplantation GM-CSF and isotretinoin after induction in children with newly diagnosed high-risk neuroblastoma
Determine the role of the meta-iodobenzylguanidine MIBG scan in assessing response to tandem transplantation and minimal residual disease therapy in these patients
Determine the feasibility of quantitative polymerase chain reaction for neuroblastoma-specific ribonucleic acids at specific stages of treatment as a prognostic indicator of outcome in these patients
Determine the immune recovery by quantitation of lymphocyte subsets in these patients and limited functional analysis after completion of this regimen
OUTLINE This is a multicenter study Patients are stratified according to peripheral blood stem cell PBSC selection selected PBSCs vs unselected PBSCs Selected PBSC stratum closed to accrual as of 71702
Inductionharvest
Course 1 Patients receive etoposide VP-16 IV over 1 hour on days 2-4 cisplatin IV over 6 hours beginning after VP-16 infusion on days 1-5 and filgrastim G-CSF subcutaneously SC beginning on day 6 and continuing until blood counts recover
Course 2 Patients receive vincristine IV and doxorubicin IV over 15 minutes on day 1 cyclophosphamide IV over 6 hours on days 1 and 2 and sargramostim GM-CSF SC beginning on day 3 and continuing until PBSC are harvested Beginning after completion of course 2 and when blood counts recover autologous PBSC are harvested
Course 3 Patients receive VP-16 IV over 1 hour and ifosfamide IV over 1 hour on days 1-5 and G-CSF SC beginning on day 6 and continuing until blood counts recover
Course 4 Patients receive VP-16 IV over 1 hour on days 1-3 carboplatin IV over 2 hours beginning after VP-16 infusion on days 1 and 2 and G-CSF SC beginning on day 4 and continuing until blood counts recover
Course 5 Patients receive treatment as in course 2 but supported by G-CSF Courses 1-5 each last 3-4 weeks Patients undergo resection of the primary tumor after course 4 or 5 unless primary resection was completed at diagnosis which is not recommended no primary site is found or the primary site is unresectable Patients complete courses 1-5 and then proceed to the first conditioningPBSC transplantation PBSCT in the absence of disease progression or unacceptable toxicity
First conditioningPBSCT Patients receive high-dose thiotepa IV on days -7 to -5 and cyclophosphamide IV over 1 hour on days -5 to -2 CD34 PBSC are reinfused on day 0 GM-CSF is administered SC beginning on day 5 and continuing until blood counts recover If blood counts have not recovered by day 28 unselected PBSC are reinfused In the absence of disease progression or unacceptable toxicity patients proceed to the second conditioningPBSCT
Second conditioningPBSCT Beginning within 6-8 weeks after initiating the first conditioning patients receive high-dose carboplatin IV continuously and etoposide phosphate IV continuously on days -7 to -4 and melphalan IV on days -7 to -5 PBSC and GM-CSF are administered as in the first PBSCT
Beginning no earlier than day 28 after the second PBSCT patients undergo local radiotherapy to the primary site and sites that are positive by meta-iodobenzylguanidine scan after induction twice a day for 7 days or once a day for 12 days if twice daily dosing is not possible Beginning on day 90 after the second PBSCT patients receive oral isotretinoin twice a day for 2 weeks Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 31-39 patients will be accrued for this study within 22 months
Determine the toxicity and feasibility of high-dose thiotepa and cyclophosphamide with autologous peripheral blood stem cell PBSC transplantation and sargramostim GM-CSF followed by high-dose carboplatin etoposide and melphalan with second PBSC transplantation GM-CSF and isotretinoin after induction in children with newly diagnosed high-risk neuroblastoma
Determine the role of the meta-iodobenzylguanidine MIBG scan in assessing response to tandem transplantation and minimal residual disease therapy in these patients
Determine the feasibility of quantitative polymerase chain reaction for neuroblastoma-specific ribonucleic acids at specific stages of treatment as a prognostic indicator of outcome in these patients
Determine the immune recovery by quantitation of lymphocyte subsets in these patients and limited functional analysis after completion of this regimen
OUTLINE This is a multicenter study Patients are stratified according to peripheral blood stem cell PBSC selection selected PBSCs vs unselected PBSCs Selected PBSC stratum closed to accrual as of 71702
Inductionharvest
Course 1 Patients receive etoposide VP-16 IV over 1 hour on days 2-4 cisplatin IV over 6 hours beginning after VP-16 infusion on days 1-5 and filgrastim G-CSF subcutaneously SC beginning on day 6 and continuing until blood counts recover
Course 2 Patients receive vincristine IV and doxorubicin IV over 15 minutes on day 1 cyclophosphamide IV over 6 hours on days 1 and 2 and sargramostim GM-CSF SC beginning on day 3 and continuing until PBSC are harvested Beginning after completion of course 2 and when blood counts recover autologous PBSC are harvested
Course 3 Patients receive VP-16 IV over 1 hour and ifosfamide IV over 1 hour on days 1-5 and G-CSF SC beginning on day 6 and continuing until blood counts recover
Course 4 Patients receive VP-16 IV over 1 hour on days 1-3 carboplatin IV over 2 hours beginning after VP-16 infusion on days 1 and 2 and G-CSF SC beginning on day 4 and continuing until blood counts recover
Course 5 Patients receive treatment as in course 2 but supported by G-CSF Courses 1-5 each last 3-4 weeks Patients undergo resection of the primary tumor after course 4 or 5 unless primary resection was completed at diagnosis which is not recommended no primary site is found or the primary site is unresectable Patients complete courses 1-5 and then proceed to the first conditioningPBSC transplantation PBSCT in the absence of disease progression or unacceptable toxicity
First conditioningPBSCT Patients receive high-dose thiotepa IV on days -7 to -5 and cyclophosphamide IV over 1 hour on days -5 to -2 CD34 PBSC are reinfused on day 0 GM-CSF is administered SC beginning on day 5 and continuing until blood counts recover If blood counts have not recovered by day 28 unselected PBSC are reinfused In the absence of disease progression or unacceptable toxicity patients proceed to the second conditioningPBSCT
Second conditioningPBSCT Beginning within 6-8 weeks after initiating the first conditioning patients receive high-dose carboplatin IV continuously and etoposide phosphate IV continuously on days -7 to -4 and melphalan IV on days -7 to -5 PBSC and GM-CSF are administered as in the first PBSCT
Beginning no earlier than day 28 after the second PBSCT patients undergo local radiotherapy to the primary site and sites that are positive by meta-iodobenzylguanidine scan after induction twice a day for 7 days or once a day for 12 days if twice daily dosing is not possible Beginning on day 90 after the second PBSCT patients receive oral isotretinoin twice a day for 2 weeks Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 31-39 patients will be accrued for this study within 22 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 |
|---|---|---|---|
| CDR0000068681 | OTHER | Clinical Trialsgov | None |
| COG-ANBL00P1 | OTHER | None | None |