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

NCT ID: NCT00798148

Last Updated: 2012-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neuroblastoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MIBG

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hematology-Oncology & SCT Research Center

Tehran, Tehran Province, Iran

Site Status RECRUITING

Research Institute for Nuclear Medicine

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Amir Ali Hamidieh, M.D.

Role: CONTACT

Facility Contacts

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Amir Ali Hamidieh, M.D.

Role: primary

Babak Fallahi, M.D.

Role: primary

Other Identifiers

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87-01-36-6853

Identifier Type: -

Identifier Source: org_study_id

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