Iodine I 131 Monoclonal Antibody 3F8 and Bevacizumab in Treating Patients With Relapsed or Refractory Neuroblastoma

Neuroblastoma Clinical Trial

Official title: Combination of Targeted I -3F8-Mediated Radioimmunotherapy and Bevacizumab in Patients With Relapsed or Refractory Neuroblastoma: A Phase I Study

Status Completed

Clinical Trial Summary

RATIONALE: Monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8 and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of neuroblastoma by blocking blood flow to the tumor. Giving iodine I 131 monoclonal antibody 3F8 together with bevacizumab may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of iodine I 131 monoclonal antibody 3F8 when given together with bevacizumab in treating patients with relapsed or refractory neuroblastoma.

Clinical Trial Description

OBJECTIVES:

Primary

• Determine the toxicity of iodine I 131 monoclonal antibody 3F8 (^131I-3F8) and bevacizumab in patients with relapsed or refractory neuroblastoma.

• Determine the hematopoietic recovery after autologous stem cell rescue in patients treated with this regimen.

Secondary

• Determine the clinical response rates in patients treated with this regimen.

• Assess whole body dosimetry for ^131I-3F8.

• Assess tumor targeting of ^131I-3F8 before and after bevacizumab.

OUTLINE: This is a dose-escalation study of iodine I 131 monoclonal antibody 3F8 (^131I-3F8).

Patients receive ^131I-3F8 IV over 20-30 minutes on day 0 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 4 courses. Patients whose blood counts do not recover and whose human antimouse antibody (HAMA) titer < 1,000 U/mL after course 1 receive one dose of ^131I-3F8 alone followed by autologous stem cell rescue (ASCR) and filgrastim (G-CSF). Patients whose blood counts do not recover and whose HAMA titer ≥ 1,000 U/mL after course 1 undergo ASCR followed by G-CSF. Patients whose blood counts recover and whose HAMA titer < 1,000 U/mL after course 1 receive 3 more courses of ^131I-3F8 and bevacizumab in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of ^131I-3F8 and bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed at 3-4 weeks and then every 3-6 months thereafter. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroblastoma

• NCT number: NCT00450827
• Study type: Interventional
• Source: Memorial Sloan Kettering Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: August 2006
• Completion date: August 2015