Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00253435
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2005-11-11
Brief Title:
N2001-02 I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
I-Metaiodobenzylguanidine MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2023-04
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 Radioactive drugs such as iodine I 131 metaiodobenzylguanidine may carry radiation directly to tumor cells and not harm normal cells Drugs used in chemotherapy such as carboplatin etoposide and melphalan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells An autologous peripheral stem cell or bone marrow transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy Giving iodine I 131 metaiodobenzylguanidine and combination chemotherapy with an autologous peripheral stem cell or bone marrow transplant may allow more chemotherapy to be given so that more tumor cells are killed Giving radiation therapy after an autologous peripheral stem cell or bone marrow transplant may kill any remaining tumor cells
PURPOSE This phase II trial is studying how well giving iodine I 131 metaiodobenzylguanidine together with combination chemotherapy and radiation therapy works in treating patients who are undergoing an autologous peripheral stem cell or bone marrow transplant for relapsed or refractory neuroblastoma
PURPOSE This phase II trial is studying how well giving iodine I 131 metaiodobenzylguanidine together with combination chemotherapy and radiation therapy works in treating patients who are undergoing an autologous peripheral stem cell or bone marrow transplant for relapsed or refractory neuroblastoma
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with relapsed or refractory neuroblastoma treated with iodine I 131 metaiodobenzylguanidine 131I-MIBG and combination chemotherapy comprising carboplatin etoposide and melphalan followed by autologous bone marrow or peripheral blood stem cell transplantation and radiotherapy
Secondary
Determine the hematopoietic and nonhematopoietic toxicity of this regimen in these patients
Determine the tumor self-absorbed radiation dose TSARD in patients with measurable soft tissue lesions treated with this regimen
Correlate the TSARD with tumor response in patients with measurable residual soft tissue disease treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to risk poor-risk group mixed or no response to induction therapy or progression during or after induction therapy vs good-risk group partial response after 4 courses of induction therapy and kidney function at study entry glomerular filtration rate GFR 100 mLmin vs GFR 60-99 mLmin
Stem cell harvest Patients undergo a peripheral blood stem cell harvest or bone marrow harvest provided they have an adequate number of cells available At least 2 weeks later patients proceed to iodine I 131 metaiodobenzylguanidine 131I-MIBG and combination chemotherapy
131I-MIBG and combination chemotherapy Patients receive 131I-MIBG IV over 2 hours on day -21 carboplatin IV continuously on days -7 to -4 etoposide IV continuously on days -7 to -4 and melphalan IV over 1 hour on days -7 to -5
Stem cell infusion and filgrastim G-CSF Three days after completion of chemotherapy patients undergo transplantation of either stem cells or bone marrow on day 0 Patients also receive G-CSF subcutaneously or IV over 1 hour once daily beginning on day 0 and continuing until blood counts return to normal
Radiotherapy Once blood counts return to normal patients undergo radiotherapy to primary and metastatic sites that have not received previous irradiation over 12 days beginning after day 42
After completion of study treatment patients are followed for 2 years and then periodically thereafter
PROJECTED ACCRUAL Approximately 50 patients 40 low-risk patients and 8-10 high-risk patients will be accrued for this study
Primary
Determine the response rate in patients with relapsed or refractory neuroblastoma treated with iodine I 131 metaiodobenzylguanidine 131I-MIBG and combination chemotherapy comprising carboplatin etoposide and melphalan followed by autologous bone marrow or peripheral blood stem cell transplantation and radiotherapy
Secondary
Determine the hematopoietic and nonhematopoietic toxicity of this regimen in these patients
Determine the tumor self-absorbed radiation dose TSARD in patients with measurable soft tissue lesions treated with this regimen
Correlate the TSARD with tumor response in patients with measurable residual soft tissue disease treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to risk poor-risk group mixed or no response to induction therapy or progression during or after induction therapy vs good-risk group partial response after 4 courses of induction therapy and kidney function at study entry glomerular filtration rate GFR 100 mLmin vs GFR 60-99 mLmin
Stem cell harvest Patients undergo a peripheral blood stem cell harvest or bone marrow harvest provided they have an adequate number of cells available At least 2 weeks later patients proceed to iodine I 131 metaiodobenzylguanidine 131I-MIBG and combination chemotherapy
131I-MIBG and combination chemotherapy Patients receive 131I-MIBG IV over 2 hours on day -21 carboplatin IV continuously on days -7 to -4 etoposide IV continuously on days -7 to -4 and melphalan IV over 1 hour on days -7 to -5
Stem cell infusion and filgrastim G-CSF Three days after completion of chemotherapy patients undergo transplantation of either stem cells or bone marrow on day 0 Patients also receive G-CSF subcutaneously or IV over 1 hour once daily beginning on day 0 and continuing until blood counts return to normal
Radiotherapy Once blood counts return to normal patients undergo radiotherapy to primary and metastatic sites that have not received previous irradiation over 12 days beginning after day 42
After completion of study treatment patients are followed for 2 years and then periodically thereafter
PROJECTED ACCRUAL Approximately 50 patients 40 low-risk patients and 8-10 high-risk patients will be accrued for this study
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 |
|---|---|---|---|
| N2001-02 | OTHER | NANT Consortium | httpsreporternihgovquickSearchP01CA081403 |
| P01CA081403 | NIH | None | None |