N2000-01: Double Infusion of Iodine I 131 Metaiodobenzylguanidine Followed by Autologous Stem Cel… (NCT00083135) | Clinical Trial Compass
CompletedPhase 1
N2000-01: Double Infusion of Iodine I 131 Metaiodobenzylguanidine Followed by Autologous Stem Cell Transplantation
United States18 participantsStarted 2004-03
Plain-language 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.
Who can participate
Age range1 Year – 30 Years
SexALL
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DISEASE CHARACTERISTICS:
* Diagnosis of neuroblastoma
* Confirmed by at least 1 of the following methods:
* Histology
* Clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
* High-risk disease
* Poor response to induction therapy OR relapse defined by any of the following:
* No response, stable disease, or mixed response after a minimum of 3 prior courses of chemotherapy
* More than 100 tumor cells per 10\^5 nucleated cells on bone marrow immunocytology after at least 3 prior courses of chemotherapy
* Progressive disease at any time during or after therapy
* Patients with massive bone marrow invasion (more than 50% replacement of bone marrow by tumor cells) are allowed
* Must have positive iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) within the past 6 weeks or subsequent to any other prior antitumor therapy delivered within the past 6 weeks
* Must meet the following criteria for minimum number of autologous stem cells:
* Unpurged peripheral blood stem cells (PBSC)
* Minimum of 1,500,000/mm\^3 CD34-positive cells/kg
* Collected products must have \< 1 tumor cell/100,000 normal cells by immunocytology
* PBSC purged with immunomagnetic beads
* Minimum of 1,000,000/mm\^3 viable CD34-positive cells/kg
* Collected products must have \< 1 tumor cell/100,000 normal cells by immunocytology
* CD34-positive selected PBSC products are not allowed
* Patients who had PBSC collected…
Trial details
NCT IDNCT00083135
SponsorNew Approaches to Neuroblastoma Therapy Consortium