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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00293319 |
RATIONALE: Radioactive drugs, such as 131 I-MIBG, may carry radiation directly to tumor cells and not harm normal cells.
PURPOSE: This phase II trial is studying how well 131 I-MIBG works in treating patients with refractory or relapsed neuroblastoma.
Condition | Intervention | Phase |
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Neuroblastoma |
Drug: filgrastim Drug: iodine I 131 metaiodobenzylguanidine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma, A Phase II Study |
Estimated Enrollment: | 50 |
Study Start Date: | April 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a compassionate use study.
Patients receive iodine I 131 metaiodobenzylguanidine IV over 2 hours. Beginning 10 days later, patients with low neutrophil counts receive filgrastim (G-CSF) subcutaneously until blood count recovers. Patients with stable or responding disease may receive a second dose of iodine I 131 metaiodobenzylguanidine at least 6 weeks after the first dose.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Ages Eligible for Study: | 1 Year and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Original diagnosis of neuroblastoma based on 1 of the following criteria:
Refractory or relapsed disease, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 3 months since prior radiotherapy to any of the following fields:
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | |
Ann Arbor, Michigan, United States, 48109-0942 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Study Chair: | Katherine K. Matthay, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Investigator: | John M. Maris, MD | Children's Hospital of Philadelphia |
Investigator: | Robert Goldsby, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000454716, UCSF-05161, UCSF-00161 |
Study First Received: | February 16, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00293319 |
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 |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Enzyme Inhibitors Neoplasms, Neuroepithelial Pharmacologic Actions |