Status:
UNKNOWN
131I-MIBG With Myeloablative Chemotherapy and Autologous Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma
Lead Sponsor:
Tehran University of Medical Sciences
Conditions:
Neuroblastoma
Eligibility:
All Genders
1-14 years
Phase:
PHASE1
PHASE2
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 ri...
Eligibility Criteria
Inclusion
- 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
- Impaired renal function
- No avid I131-MIBG lesion
- Active infection
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00798148
Start Date
September 1 2008
Last Update
June 4 2012
Active Locations (2)
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1
Hematology-Oncology & SCT Research Center
Tehran, Tehran Province, Iran, 14114
2
Research Institute for Nuclear Medicine
Tehran, Tehran Province, Iran, 14114