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

Phase 1

• Conditions: Neuroblastoma
• Interventions: Drug: 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation

• Registration Number: NCT00798148
• Lead Sponsor: Tehran University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-11-23
• Study First Submitted QC: 2008-11-23
• Study First Posted: 2008-11-25
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04
• Primary Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MIBG	131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation	-

Primary Outcome Measures

Name	Time	Method
Response (complete response, very good partial response, and partial response) at one-years post stem cell transplantation	one-years post stem cell transplantation

Secondary Outcome Measures

Name	Time	Method
Overall survival	one-year after stem cell tranplantation

Trial Locations

Locations (2)

Hematology-Oncology & SCT Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of

Research Institute for Nuclear Medicine; 🇮🇷 Tehran, Iran, Islamic Republic of