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

• Sponsor: Tehran University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00798148
• Collaborator: (none)
• Enrollment: 10
• Locations: 2
• Arm: 1
• Patients Per Site: 5

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Neuroblastoma	Drug: 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Sep 1, 2008
• Anticipated Primary Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MIBG	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

Outcome Measures

Primary Outcome Measures

1. Response (complete response, very good partial response, and partial response) at one-years post stem cell transplantation [one-years post stem cell transplantation]

Secondary Outcome Measures

1. Overall survival [one-year after stem cell tranplantation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hematology-Oncology & SCT Research Center	Tehran		Iran, Islamic Republic of	14114
2	Research Institute for Nuclear Medicine	Tehran		Iran, Islamic Republic of	14114

Sponsors and Collaborators

• Tehran University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tehran University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT00798148
• Other Study ID Numbers: 87-01-36-6853
• First Posted: Nov 25, 2008
• Last Update Posted: Jun 4, 2012
• Last Verified: May 1, 2012

• Keywords provided by Tehran University of Medical Sciences: Neuroblastoma; MIBG; Autologous Peripheral Stem Cell Transplantation
• Additional relevant MeSH terms: Neuroblastoma; Carboplatin; Etoposide; Melphalan

Study Results

No Results Posted as of Jun 4, 2012