Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005978
Status:
COMPLETED
Last Update Posted:
2010-10-15
First Post:
2000-07-05
Brief Title:
N99-01 Combination Chemotherapy Radiation Therapy and Stem Cell Transplantation in Treating Patients With Neuroblastoma
Sponsor:
New Approaches to Neuroblastoma Therapy Consortium
Organization:
New Approaches to Neuroblastoma Therapy Consortium
Study Overview
Official Title:
Dose Escalation Study of 131 I-Metaiodobenzylguanidine MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma - A Phase I Study
Status:
COMPLETED
Status Verified Date:
2009-05
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 work in different ways to stop tumor cells from dividing so they stop growing or die Giving the drugs in different ways may kill more tumor cells Radiation therapy uses high-energy x-rays to damage tumor cells Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy
PURPOSE This phase I trial is studying the side effects and best dose of combination chemotherapy when given before stem cell transplant and radiation therapy in treating patients with neuroblastoma that has not responded to previous treatments
PURPOSE This phase I trial is studying the side effects and best dose of combination chemotherapy when given before stem cell transplant and radiation therapy in treating patients with neuroblastoma that has not responded to previous treatments
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and toxic effects of iodine I 131 metaiodobenzylguanidine 131 I-MIBG plus ablative doses of carboplatin and etoposide administered with fixed-dose melphalan followed by autologous hematopoietic stem cell transplantation in patients with refractory or residual high-risk neuroblastoma
Determine the number of days until blood counts recover in these patients after receiving this treatment regimen
Determine the response rate to this treatment regimen in these patients
Determine the tumor dosimetry of 131 I-MIBG in patients with measurable soft tissue lesions
OUTLINE This is a dose-escalation study of iodine I 131 metaiodobenzylguanidine 131 I-MIBG carboplatin and etoposide Patients are stratified according to glomerular filtration rate at least 100 mLmin vs 60-99 mLmin
Patients undergo peripheral blood stem cell harvest or bone marrow harvest at least 2 weeks prior to treatment with 131 I-MIBG
Patients receive 131 I-MIBG IV over 120 minutes on day -21 melphalan IV on days -7 to -5 carboplatin and etoposide IV continuously over 96 hours on days -7 to -4 autologous hematopoietic stem cell transplantation IV over 15-30 minutes on day 0 and filgrastim G-CSF subcutaneously or IV starting on day 0 and continuing until blood counts recover Radiotherapy is administered to the primary tumor site and metastatic sites twice daily for 7 consecutive days within 6 weeks of transplantation or once blood counts have recovered
Cohorts of 3-6 patients receive escalating doses of 131 I-MIBG carboplatin and etoposide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Patients are followed at day 84 and then 2 months later if there is a complete response andor partial response Patients who continue therapy on other protocols are followed before starting the new therapy All patients are followed for life for any delayed toxic effects related to study therapy secondary malignancies disease status and survival
PROJECTED ACCRUAL A total of 30-60 patients 15-30 per stratum will be accrued for this study within 2-3 years
Determine the maximum tolerated dose and toxic effects of iodine I 131 metaiodobenzylguanidine 131 I-MIBG plus ablative doses of carboplatin and etoposide administered with fixed-dose melphalan followed by autologous hematopoietic stem cell transplantation in patients with refractory or residual high-risk neuroblastoma
Determine the number of days until blood counts recover in these patients after receiving this treatment regimen
Determine the response rate to this treatment regimen in these patients
Determine the tumor dosimetry of 131 I-MIBG in patients with measurable soft tissue lesions
OUTLINE This is a dose-escalation study of iodine I 131 metaiodobenzylguanidine 131 I-MIBG carboplatin and etoposide Patients are stratified according to glomerular filtration rate at least 100 mLmin vs 60-99 mLmin
Patients undergo peripheral blood stem cell harvest or bone marrow harvest at least 2 weeks prior to treatment with 131 I-MIBG
Patients receive 131 I-MIBG IV over 120 minutes on day -21 melphalan IV on days -7 to -5 carboplatin and etoposide IV continuously over 96 hours on days -7 to -4 autologous hematopoietic stem cell transplantation IV over 15-30 minutes on day 0 and filgrastim G-CSF subcutaneously or IV starting on day 0 and continuing until blood counts recover Radiotherapy is administered to the primary tumor site and metastatic sites twice daily for 7 consecutive days within 6 weeks of transplantation or once blood counts have recovered
Cohorts of 3-6 patients receive escalating doses of 131 I-MIBG carboplatin and etoposide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Patients are followed at day 84 and then 2 months later if there is a complete response andor partial response Patients who continue therapy on other protocols are followed before starting the new therapy All patients are followed for life for any delayed toxic effects related to study therapy secondary malignancies disease status and survival
PROJECTED ACCRUAL A total of 30-60 patients 15-30 per stratum will be accrued for this study within 2-3 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 |
|---|---|---|---|
| P01CA081403 | NIH | None | None |
| N99-01 | OTHER | NANT Consortium | httpsreporternihgovquickSearchP01CA081403 |