NCT00798148

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Last Updated

June 4, 2012

Status Verified

May 1, 2012

Enrollment Period

3.8 years

First QC Date

November 23, 2008

Last Update Submit

May 31, 2012

Conditions

Neuroblastoma

Keywords

NeuroblastomaMIBGAutologous Peripheral Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

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

    one-years post stem cell transplantation

Secondary Outcomes (1)

  • Overall survival

    one-year after stem cell tranplantation

Study Arms (1)

MIBG

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

Interventions

131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell TransplantationDRUG

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

MIBG

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hematology-Oncology & SCT Research Center

Tehran, Tehran Province, 14114, Iran

RECRUITING

Research Institute for Nuclear Medicine

Tehran, Tehran Province, 14114, Iran

RECRUITING

MeSH Terms

Conditions

Neuroblastoma

Interventions

3-IodobenzylguanidineEtoposideMelphalanCarboplatin

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsIodobenzenesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsHydrocarbons, IodinatedHydrocarbons, HalogenatedPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesNitrogen Mustard CompoundsMustard CompoundsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsCoordination Complexes

Central Study Contacts

Amir Ali Hamidieh, M.D.

CONTACT

aahamidieh@sina.tums.ac.ir

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2008

First Posted

November 25, 2008

Study Start

September 1, 2008

Primary Completion

July 1, 2012

Last Updated

June 4, 2012

Record last verified: 2012-05

Locations

IR(2)