High-Dose Iodine I 131 Metaiodobenzylguanidine, Topotecan, and Peripheral Stem Cell Transplant in Treating Young Patients With Relapsed Stage 4 Neuroblastoma or Primary Resistant High-Risk Neuroblastoma

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radioisotope therapy, such as iodine I 131 metaiodobenzylguanidine (MIBG), releases radiation that kills tumor cells. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Topotecan may also make tumor cells more sensitive to iodine I 131 MIBG. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by iodine I 131 MIBG and topotecan. This may allow more iodine I 131 MIBG and topotecan to be given so that more tumor cells are killed.

PURPOSE: This phase II trial is studying how well giving high-dose iodine I 131 MIBG together with topotecan and peripheral stem cell transplant works in treating young patients with relapsed stage 4 neuroblastoma or primary resistant high-risk neuroblastoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Cancer and Leukaemia Group
• Treatments: 3-Iodobenzylguanidine; Iodine; Topotecan

Criteria

DISEASE CHARACTERISTICS:

• Confirmed diagnosis of neuroblastoma meeting the 1 of the following criteria:

• Primary resistant high-risk disease meeting the following criteria:

• International neuroblastoma staging system (INSS) stage 4, or stage 2 or 3 with myelocytomatosis viral-related oncogene (MycN) amplification

• Failed to achieve satisfactory remission with induction chemotherapy, defined as one of the following:

• Less than 50% reduction or > 3 positive sites on iodine I 131 metaiodobenzylguanidine (^131I-MIBG) scintigraphy

• Persistent cytomorphological positive disease in bone marrow aspirates or trephine biopsies

• Progressive disease necessitating a change of treatment

• Relapsed stage 4 disease meeting the following criteria:

• High-risk neuroblastoma (INSS stage 4, or stage 2 or 3 with MycN amplification)

• Relapsed after intensive treatment including high-dose chemotherapy and hematopoietic progenitor cell support

• Patients may be entered at the time of relapse, or at any point subsequently after other treatments

• ^131I-MIBG-positive disease on diagnostic scintigraphy

• Peripheral blood stem cell harvest ≥ 300,000/mm³ CD 34+ cells

• Enrolled in or has been treated on protocol SIOP-NB-2009 or a similar protocol

PATIENT CHARACTERISTICS:

• Glomerular filtration rate ≥ 50 mL/min

• Considered fit enough to undergo proposed study treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics