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Study 6 of 155 for search of: | Iran, Islamic Republic of |
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Sponsored by: |
Tehran University of Medical Sciences |
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Information provided by: | Tehran University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00798148 |
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 |
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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 |
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 |
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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
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Ages Eligible for Study: | 1 Year to 14 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amir Ali Hamidieh, M.D. | aahamidieh@sina.tums.ac.ir |
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. |
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 |
Neuroblastoma MIBG Autologous Peripheral Stem Cell Transplantation |
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 |
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 |