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

This study is currently recruiting participants.

Verified by Tehran University of Medical Sciences, August 2008

Sponsored by:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00798148

Purpose

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.

Condition	Intervention	Phase
Neuroblastoma	Drug: 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation	Phase I Phase II

MedlinePlus related topics: Neuroblastoma

Drug Information available for: Carboplatin Etoposide Melphalan Etoposide phosphate Melphalan hydrochloride Sarcolysin 3-Iodobenzylguanidine Iobenguane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall survival [ Time Frame: one-year after stem cell tranplantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	September 2008
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MIBG: Experimental	Drug: 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

Eligibility

Ages Eligible for Study:	1 Year to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798148

Contacts

Contact: Amir Ali Hamidieh, M.D.

aahamidieh@sina.tums.ac.ir

Locations

Iran, Islamic Republic of
Hematology-Oncology & SCT Research Center	Recruiting
Tehran, Iran, Islamic Republic of, 14114
Contact: Amir Ali Hamidieh, M.D. aahamidieh@sina.tums.ac.ir
Principal Investigator: Amir Ali Hamidieh, M.D.
Research Institute for Nuclear Medicine	Recruiting
Tehran, Iran, Islamic Republic of, 14114
Contact: Babak Fallahi, M.D. bfallahi@sina.tums.ac.ir
Principal Investigator: Babak Fallahi, M.D.

Sponsors and Collaborators

Tehran University of Medical Sciences

More Information

Responsible Party:	Tehran University of Medical Sciences ( Tehran University of Medical Sciences )
Study ID Numbers:	87-01-36-6853
Study First Received:	November 23, 2008
Last Updated:	November 23, 2008
ClinicalTrials.gov Identifier:	NCT00798148
Health Authority:	Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:

Neuroblastoma
MIBG
Autologous Peripheral Stem Cell Transplantation

Study placed in the following topic categories:

Melphalan
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
3-Iodobenzylguanidine
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Carboplatin
Etoposide phosphate
Etoposide
Neuroectodermal Tumors, Primitive, Peripheral
Neuroblastoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents

Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009