A Phase I Study of Humanized 3F8 plus Interleukin-2 in Patients with High-Risk Neuroblastoma and GD2-Positive Tumors

Protocol
12-116
Full Title
Phase I Study of Humanized 3F8 Monoclonal Antibody (Hu3F8) when Combined with Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors
Phase
I
Disease Status
Relapsed/Refractory
Purpose

3F8 is an antibody that attaches to neuroblastoma cells and helps focus a patient’s own immune system - especially white blood cells - to attack neuroblastoma cells. Conventional 3F8 is made from mouse cells.

In this study, investigators want to find the optimal dose of humanized 3F8 (Hu3F8) that can be given with the drug interleukin-2 (IL-2) in patients with neuroblastoma and GD2-positive tumors that have continued to grow or have not responded to standard therapy. Hu3F8 is made to be more like the human immune system than a mouse’s immune system, so it may be associated with fewer side effects in patients than standard mouse-derived 3F8.

Il-2 is a drug approved for treating melanoma and kidney cancer, but its use in this study is considered investigational. It works by activating the immune system.

Eligibility

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

  • Patients must have high-risk neuroblastoma or a metastatic tumor that expresses the GD2 protein and has returned or continued to grow despite standard therapy.
  • Patients must be over age 1 year.
  • Prior treatment with murine 3F8 is permitted.
  • At least 3 weeks must have passed since completion of prior chemotherapy or immunotherapy and entry into the study.

For more information about this study and to inquire about eligibility, please contact Dr. Stephen Roberts at 212-639-4034.

Disease(s)
Neuroblastoma
Sarcomas: Osteosarcoma
Sarcomas: Soft Tissue Sarcoma
Locations