N2000-01: Double Infusion of Iodine I 131 Metaiodobenzylguanidine Followed by Autologous Stem Cell Transplantation

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Lead sponsor: Children's Hospital Los Angeles to New Approaches to Neuroblastoma Therapy Consortiumv24
  2. Lead sponsor: New Approaches to Neuroblastoma Therapy Consortium to Children's Hospital Los Angeles
    • Study title shortened, about 5 words
    v23
  3. Publications: 1 to 2v22
  4. Trial status: Active, Not Recruiting to Completed
    • Primary completion date: Feb 2006
    v21
  5. Interventions: autologous bone marrow transplantation (Procedure), filgrastim (Biological), iodine I 131 metaiodobenzylguanidine (Radiation), peripheral… to autologous bone marrow transplantation (Procedure), filgrastim (Biological), iobenguane I 131 (Radiation), peripheral blood stem cell…v20
Show 18 earlier versionsHide 18 earlier versions
  1. Study Status, Referencesv19
  2. Interventions: autologous bone marrow transplantation (Procedure), filgrastim (Drug), iodine I 131 metaiodobenzylguanidine (Drug), peripheral blood stem… to autologous bone marrow transplantation (Procedure), filgrastim (Biological), iodine I 131 metaiodobenzylguanidine (Radiation), peripheral…v18
  3. Re-verified, no change to tracked fieldsv17
  4. Interventions: autologous bone marrow transplantation (Procedure), colony-stimulating factor therapy (Procedure), filgrastim (Drug), iodine I 131… to autologous bone marrow transplantation (Procedure), filgrastim (Drug), iodine I 131 metaiodobenzylguanidine (Drug), peripheral blood stem…v16
  5. 2 versions Re-verified since Dec 1, 2007, no change to tracked fieldsv14-v15
  6. Interventions: autologous bone marrow transplantation (Procedure), biological therapy (Procedure), bone marrow ablation with stem cell support… to autologous bone marrow transplantation (Procedure), colony-stimulating factor therapy (Procedure), filgrastim (Drug), iodine I 131…v13
  7. Lead sponsor: National Cancer Institute (NCI) to New Approaches to Neuroblastoma Therapy Consortiumv12 Show 4 more changesShow less
    • Enrollment target: 18
    • Start date: Mar 2004
    • Study description expanded, about 5 words
    • Collaborators expanded, about 4 words
  8. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 7 of 7 sites
    v11
  9. Re-verified, no change to tracked fieldsv10
  10. Interventions: autologous bone marrow transplantation (Procedure), biological response modifier therapy (Procedure), bone marrow ablation with stem cell… to autologous bone marrow transplantation (Procedure), biological therapy (Procedure), bone marrow ablation with stem cell support…v9
  11. Study sites revised (7)v8
  12. Site contacts updated at 1 of 7 sitesv7
  13. Site contacts updated at 4 of 7 sitesv6
  14. Study sites: 9 to 7v5
  15. Site contacts updated at 1 of 9 sitesv4
  16. Study sites: 8 to 9v3
  17. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00083135
Lead Sponsor New Approaches to Neuroblastoma Therapy Consortium
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Neuroblastoma
Related terms Neuroblastoma
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Updated on ClinicalTrials.gov