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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00798148

Enrollment

Registered

2008-11-25

Start date

2008-09-30

Completion date

Unknown

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroblastoma

Keywords

Neuroblastoma, MIBG, Autologous Peripheral Stem Cell Transplantation

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.

Interventions

DRUG131I-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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 14 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Overall survival	one-year after stem cell tranplantation

Countries

Iran

Contacts

Primary ContactAmir Ali Hamidieh, M.D.

aahamidieh@sina.tums.ac.ir

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026