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

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Neuroblastoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00798148

87-01-36-6853

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 1 to 14 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

MIBG

Experimental group

Treatment:

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