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Combination of Targeted I¹³¹-3F8-Mediated Radioimmunotherapy and Bevacizumab in Patients with Relapsed or Refractory Neuroblastoma: A Phase I Study

[Protocol 06-072]

Full Title :

COMBINATION OF TARGETED 131I-3F8-MEDIATED RADIOIMMUNOTHERAPY AND BEVACIZUMAB IN PATIENTS WITH RELAPSED OR REFRACTORY NEUROBLASTOMA: A PHASE I STUDY

Purpose :

Neuroblastoma is a solid tumor that mainly affects young persons and can be very difficult to treat successfully. Although a combination of chemotherapy, radiation therapy, and surgery can help patients with advanced disease achieve remission, many patients experience a relapse of their disease. Because of this outcome, as well as the side effects associated with treatment, doctors are continually pursuing new, more effective and safer therapies.

The purpose of this study is to evaluate a combination of two drugs, I¹³¹-3F8 and bevacizumab, in patients with neuroblastoma that has returned despite or is resistant to currently available treatments I¹³¹-3F8 is an antibody with radioactive iodine attached to it. The antibody portion of the drug binds to neuroblastoma cells, and the radioactive iodine can kill the cancer cells. I¹³¹-3F8 has been assessed in prior clinical trials of patients with neuroblastoma.

Bevacizumab is a drug approved for treating patients with advanced colorectal cancer, but its use in patients with neuroblastoma is considered investigational. Bevacizumab works by attaching to a protein in the blood stream called vascular endothelial growth factor, which helps tumors grow new blood vessels to feed themselves. Bevacizumab is thought to help block this new growth of blood vessels and starve the tumors of the nutrients they need.

Laboratory studies have suggested that I¹³¹-3F8 may work better when it is given with bevacizumab. In this study, investigators will determine the highest dose of I¹³¹-3F8 that can be given safely at the same time as bevacizumab in children with relapsed or resistant neuroblastoma.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have a confirmed diagnosis of neuroblastoma that has returned after prior therapy or does not respond to currently available therapies.
• At least 3 weeks must have passed since prior chemotherapy or immunotherapy, 2 weeks since any biologic therapy, and 4 weeks since any major surgery and entry into the study.
• Patients must be older than age 1.

For more information and to see if your child is eligible for this study, please contact Dr. Shakeel Modak at 212-639-7623 or via e-mail at modaks@mskcc.org.