Clinical Trial · NCT00509353

N2004-06: Irinotecan and Vincristine With 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma

Overview

RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIGB), may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as irinotecan and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving iodine I 131 MIGB together with irinotecan and vincristine may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of iodine I 131 MIGB when given together with irinotecan and vincristine in treating young patients with resistant or relapsed high-risk neuroblastoma.

Sponsor

Unknown Organization

Phase

Phase 1

Contacts

Steven DuBois, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00509353

Drug / Compound

MIBG

Isotope(s):

Target(s):

Ligand Class: Small Molecules

Eligibility

Inclusion

Must have a diagnosis of neuroblastoma by histologic verification and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines
Refractory disease (i.e., less than a partial response to frontline therapy, including a minimum of 4 courses of chemotherapy)
Must have evidence of MIBG uptake into tumor at ≥ 1 site within 4 weeks prior to study entry and subsequent to any intervening therapy
If the patient has not had previous myeloablative therapy, preference will be given to NANT-2001-02 (iodine I 131 metaiodobenzylguanidine \[\^131I-MIBG\] + CEM)
Persistent disease after at least a partial response to frontline therapy (i.e., patient still has residual disease by MIBG scan, CT/MRI scan, or bone marrow)

Exclusion

Exclusion criteria not yet provided.