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, February 2009

First Received: November 23, 2008 Last Updated: February 21, 2009 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Neuroblastoma

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

U.S. FDA Resources

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

No publications provided

Responsible Party:	Hematology-Oncology and SCT Research Center ( Mahdi Jalili M.D. )
Study ID Numbers:	87-01-36-6853
Study First Received:	November 23, 2008
Last Updated:	February 21, 2009
ClinicalTrials.gov Identifier:	NCT00798148 History of Changes
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, Primitive
Immunologic Factors
Carboplatin
Immunosuppressive Agents
Etoposide phosphate
Neuroblastoma
Neuroectodermal Tumors
3-Iodobenzylguanidine

Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Antineoplastic Agents, Alkylating
Alkylating Agents
Etoposide
Antineoplastic Agents, Phytogenic
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Melphalan
Neuroectodermal Tumors, Primitive
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Neuroblastoma
3-Iodobenzylguanidine
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Etoposide
Alkylating Agents

Neoplasms by Histologic Type
Enzyme Inhibitors
Carboplatin
Immunosuppressive Agents
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Antineoplastic Agents, Phytogenic
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009