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NCT00798148 Clinical Trial

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

Neuroblastoma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00798148
Other study ID # 87-01-36-6853
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received November 23, 2008
Last updated May 31, 2012
Start date September 2008

Study information
Verified date May 2012
Source Tehran University of Medical Sciences
Contact Amir Ali Hamidieh, M.D.
Email aahamidieh@sina.tums.ac.ir
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 14 Years
Eligibility 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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation
131I-MIBG 12mci/kg CEM(Etoposide)=1200mg/m2 Melphalan=210mg/m2 Carboplatin=1500mg/m2 Autologous Peripheral Stem Cell Transplantation

Locations
Country Name City State
Iran, Islamic Republic of Hematology-Oncology & SCT Research Center Tehran
Iran, Islamic Republic of Research Institute for Nuclear Medicine Tehran

Sponsors (1)
Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response (complete response, very good partial response, and partial response) at one-years post stem cell transplantation one-years post stem cell transplantation Yes
Secondary Overall survival one-year after stem cell tranplantation Yes
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