131I-MIBG With Myeloablative Chemotherapy and Autologous Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma

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

Summary

This trial is studying how well iodine I 131 metaiodobenzylguanidine together with combination chemotherapy works in treating patients who are undergoing an autologous peripheral stem cell for high risk or relapsed neuroblastoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tehran University of Medical Sciences
• Treatments: 3-Iodobenzylguanidine; Carboplatin; Etoposide; Etoposide phosphate; Melphalan

Criteria

Inclusion Criteria:

• Histologically confirmed Neuroblastoma and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites

• High risk according COG (Children Oncology Group)OR Relapse OR Refractory

• As at least one I131-MIBG avid target lesion determined by diagnostic MIBG scan

• Glomerular filtration rate or creatinine clearance > 60 ml/min

• No tumor cell in Bone Marrow by routine morphology aspiration and biopsy before peripheral stem cell collection

• No active infection

Exclusion Criteria:

• Impaired renal function

• No avid I131-MIBG lesion

• Active infection