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

Primary Purpose

Neuroblastoma

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring Neuroblastoma, MIBG, Autologous Peripheral Stem Cell Transplantation

Eligibility Criteria

1 Year - 14 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Hematology-Oncology & SCT Research CenterRecruiting
  • Research Institute for Nuclear MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MIBG

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival

Full Information

First Posted
November 23, 2008
Last Updated
May 31, 2012
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00798148
Brief Title
131I-MIBG With Myeloablative Chemotherapy and Autologous Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma
Keywords
Neuroblastoma, MIBG, Autologous Peripheral Stem Cell Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIBG
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation
Intervention Description
131I-MIBG 12mci/kg CEM(Etoposide)=1200mg/m2 Melphalan=210mg/m2 Carboplatin=1500mg/m2 Autologous Peripheral Stem Cell Transplantation
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Overall survival
Time Frame
one-year after stem cell tranplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Ali Hamidieh, M.D.
Email
aahamidieh@sina.tums.ac.ir
Facility Information:
Facility Name
Hematology-Oncology & SCT Research Center
City
Tehran
ZIP/Postal Code
14114
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Ali Hamidieh, M.D.
Email
aahamidieh@sina.tums.ac.ir
First Name & Middle Initial & Last Name & Degree
Amir Ali Hamidieh, M.D.
Facility Name
Research Institute for Nuclear Medicine
City
Tehran
ZIP/Postal Code
14114
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Babak Fallahi, M.D.
Email
bfallahi@sina.tums.ac.ir
First Name & Middle Initial & Last Name & Degree
Babak Fallahi, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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