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Sponsors and Collaborators: |
New Approaches to Neuroblastoma Therapy Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00083135 |
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.
Condition | Intervention | Phase |
---|---|---|
Neuroblastoma |
Biological: filgrastim Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: iobenguane I 131 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | I-MIBG Escalating Dose Rapid Sequence Double Infusion Followed By Autologous Stem Cell Infusion For Refractory Neuroblastoma |
Estimated Enrollment: | 18 |
Study Start Date: | March 2004 |
Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation, multicenter study.
PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 1 Year to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of neuroblastoma
Confirmed by at least 1 of the following methods:
High-risk disease
Poor response to induction therapy OR relapse defined by any of the following:
Must meet the following criteria for minimum number of autologous stem cells:
Unpurged peripheral blood stem cells (PBSC)
PBSC purged with immunomagnetic beads
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Children's Hospital Los Angeles | |
Los Angeles, California, United States, 90027-0700 | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94143 | |
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202-5289 | |
United States, Massachusetts | |
Children's Hospital Boston | |
Boston, Massachusetts, United States, 02115 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229-3039 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 |
Study Chair: | Katherine K. Matthay, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Investigator: | Gregory Yanik, MD | University of Michigan Cancer Center |
Investigator: | John M. Maris, MD | Children's Hospital of Philadelphia |
Study ID Numbers: | CDR0000363631, NANT-2000-01 |
Study First Received: | May 14, 2004 |
Last Updated: | May 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00083135 History of Changes |
Health Authority: | United States: Federal Government |
recurrent neuroblastoma |
Neuroectodermal Tumors Neuroectodermal Tumors, Primitive 3-Iodobenzylguanidine Neoplasms, Germ Cell and Embryonal Iodine |
Neuroepithelioma Neuroectodermal Tumors, Primitive, Peripheral Recurrence Neuroblastoma Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Enzyme Inhibitors Pharmacologic Actions Neuroblastoma |
Neuroectodermal Tumors Neoplasms 3-Iodobenzylguanidine Neoplasms, Germ Cell and Embryonal Therapeutic Uses Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |