Evaluation of Benefit and Side Effects of 131I-MIBG in Combination With Myeloablative Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma
Phase 1/Phase 2
1 Year
14 Years
1 Year
14 Years
Open (Enrolling)
Both
Neuroblastoma
Both
Neuroblastoma
Trial Information
Evaluation of Benefit and Side Effects of 131I-MIBG in Combination With Myeloablative Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response (complete response, very good partial response, and partial response) at one-years post stem cell transplantation
Outcome Time Frame:
one-years post stem cell transplantation
Safety Issue:
Yes
Authority:
Iran: Ministry of Health
Study ID:
87-01-36-6853
NCT ID:
NCT00798148
Start Date:
September 2008
Completion Date:
Related Keywords:
- Neuroblastoma
- Neuroblastoma
- MIBG
- Autologous Peripheral Stem Cell Transplantation
- Neuroblastoma
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