N2000-01: Double Infusion of Iodine I 131 Metaiodobenzylguanidine Followed by Autologous Stem Cell Transplantation
NCT00083135 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-04-14
Summary
RATIONALE: Giving iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) may kill neuroblastoma cells by delivering radiation directly to the tumor. A stem cell transplant using the patient's stem cells may be able to replace blood-forming cells destroyed by radiation therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of a double infusion of \^131I-MIBG followed by autologous stem cell transplantation in treating patients with refractory neuroblastoma.
Conditions
Interventions
- BIOLOGICAL
- PROCEDURE
-
autologous bone marrow transplantation
- PROCEDURE
-
peripheral blood stem cell transplantation
- RADIATION
-
iobenguane I 131
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
New Approaches to Neuroblastoma Therapy Consortium
lead OTHER
Principal Investigators
-
Katherine K. Matthay, MD · University of California, San Francisco
-
Gregory Yanik, MD · University of Michigan Rogel Cancer Center
-
John M. Maris, MD · Children's Hospital of Philadelphia
Study Design
- Purpose
- TREATMENT
Eligibility
- Min Age
- 1 Year
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-03-31
- Primary Completion
- 2006-02-28
Countries
- United States
Study Locations
More Related Trials
-
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
NCT03126916 ·Status: RECRUITING ·Phase: PHASE3
-
N2004-06: Irinotecan and Vincristine With 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma
NCT00509353 ·Status: COMPLETED ·Phase: PHASE1
-
131I-MIBG With Myeloablative Chemotherapy and Autologous Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma
NCT00798148 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
MIBG Therapy for Patients With MIBG Avid Tumors
NCT02378428 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
MIBG With Dinutuximab +/- Vorinostat
NCT03332667 ·Status: COMPLETED ·Phase: PHASE1
-
Observation, Combination Chemotherapy, Radiation Therapy, and/or Autologous Stem Cell Transplant in Treating Young Patients With Neuroblastoma
NCT00410631 ·Status: UNKNOWN ·Phase: PHASE3
-
Efficacy and Safety of Ultratrace™ Iobenguane I 131 in Neuroblastoma
NCT00992173 ·Status: WITHDRAWN ·Phase: PHASE2
-
Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)
NCT04385277 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
High-Dose 131I-MIBG Therapy Combined With Vincristine and Five Days of Irinotecan for Resistant/Relapsed Neuroblastoma
NCT01313936 ·Status: COMPLETED ·Phase: PHASE1
-
Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor
NCT00003211 ·Status: COMPLETED ·Phase: PHASE2
-
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
NCT00004188 ·Status: COMPLETED ·Phase: PHASE3
-
Therapy for Children With Neuroblastoma
NCT00135135 ·Status: COMPLETED ·Phase: PHASE2
-
CHP677: I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma: a Phase II Study
NCT00013806 ·Status: UNKNOWN ·Phase: PHASE2
-
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor
NCT00003273 ·Status: WITHDRAWN ·Phase: PHASE2
-
Intensive Chemo-Radiotherapy With Peripheral Blood Progenitor Cell Rescue for Children With Advanced Neuroblastoma and Sarcomas
NCT00165139 ·Status: COMPLETED ·Phase: PHASE2
-
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
NCT04211675 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Chemotherapy, Radiation Therapy, Immunotherapy, and Bone Marrow Transplantation in Treating Patients With Neuroblastoma
NCT00002634 ·Status: COMPLETED ·Phase: PHASE2
-
Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma
NCT00567567 ·Status: COMPLETED ·Phase: PHASE3
-
Expanded Access Protocol Using 131I-MIBG Therapy +/- Vorinostat for Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma
NCT01838187 ·Status: NO_LONGER_AVAILABLE
-
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Neuroblastoma
NCT00017368 ·Status: COMPLETED ·Phase: PHASE2
-
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
NCT06172296 ·Status: RECRUITING ·Phase: PHASE3
-
Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma
NCT00526318 ·Status: UNKNOWN ·Phase: NA
-
Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
NCT00017225 ·Status: COMPLETED ·Phase: PHASE2
-
Etoposide Plus Radiation Therapy Followed by Combination Chemotherapy in Treating Children With Newly Diagnosed Advanced Medulloblastoma
NCT00003573 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of 2 Intensification Treatment Strategies for Neuroblastoma Patients With a Poor Response to Induction
NCT03165292 ·Status: TERMINATED ·Phase: PHASE2