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Status unknownNCT00798148Updated Jun 4, 2012

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

A Phase 1/2 interventional study of 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation in Neuroblastoma, sponsored by Tehran University of Medical Sciences. Status unknown at 2 sites in Iran, Islamic Republic of. Open to participants aged 1 Year to 14 Years. Per ClinicalTrials.gov, last updated 2012-06-04.

Sponsored by Tehran University of Medical Sciences · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
1 Year to 14 Years
Sex
All
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Study 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.

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Conditions studied

  • Neuroblastoma

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Keywords

  • Neuroblastoma
  • MIBG
  • Autologous Peripheral Stem Cell Transplantation
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In context

Neuroblastoma

625 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.

This study's planned enrollment of 10 is below the median of 32 across 475 interventional studies indexed under Neuroblastoma.

Browse Neuroblastoma studies →

Lead sponsor

Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Impaired renal function
  • No avid I131-MIBG lesion
  • Active infection
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    MIBG

    Drug: 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation

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

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What researchers measure

Primary outcomes

  1. Response (complete response, very good partial response, and partial response) at one-years post stem cell transplantation

    Time frame: one-years post stem cell transplantation

Secondary outcomes

  1. Overall survival

    Time frame: one-year after stem cell tranplantation

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Study locations

2 of 2 sites recruiting
  • Hematology-Oncology & SCT Research Center
    Tehran, 14114, Iran, Islamic Republic of
    Recruiting
  • Research Institute for Nuclear Medicine
    Tehran, 14114, Iran, Islamic Republic of
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00798148
Lead sponsor
Tehran University of Medical Sciences
Responsible party
Sponsor
First posted
Nov 25, 2008
Start date
Sep 2008
Primary completion
Jul 2012 (estimated)
Last update
Jun 4, 2012

Study contacts

Amir Ali Hamidieh, M.D.
Contact
aahamidieh@sina.tums.ac.ir
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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