A Phase I/II Study Using Allogeneic Tumor Cell Vaccination With Oral Metronomic Cytoxan in Patients With High-Risk Neuroblastoma (ATOMIC)
Neuroblastoma is the second most common solid tumor seen in children, but causes approximately 15% of childhood cancer deaths each year. Patients with high-risk disease require treatment with a combination of chemotherapy, surgery, radiation, and stem cell transplant; however, many will have their disease come back within 3 years. Due to this high rate of relapse, this study is being done to investigate an experimental treatment option for children whose disease has returned. This clinical trial is for patients with neuroblastoma that has either come back after treatment or never went away in the first place. A series of immunizations will be administered using a tumor vaccine and add low-dose chemotherapy to be taken by mouth on a daily basis. The hope is that the vaccine will cause the immune system to recognize and kill more types of neuroblastoma tumors. Additionally, the immunizations will be combined with daily low dose chemotherapy. Daily low-dose chemotherapy, also know as metronomic chemotherapy, works by attacking the blood vessels that allow tumors to grow. Using metronomic doses of a drug called cytoxan can also decrease T regulatory cells, a specific type of cell that tumors use to hide from the immune system. The purpose of this study is to test the safety and anti-tumor effect of the tumor cell vaccination plus low dose, metronomic chemotherapy in treating patients with relapsed/refractory neuroblastoma.
• Histologically proven high risk neuroblastoma in first or subsequent relapse or with primary refractory disease or inability to complete standard therapy
• Age less than 21 at time of initial diagnosis
• Life expectancy 12 weeks or greater
• Karnofsky or Lansky score of 50 or greater
• Platelet count of 50,000/ul or greater
• ANC greater than 750/ul
• Alk Phos level less than 2.5 x upper limit of normal
• Bilirubin less than 2x normal
• AST less than 3x normal
• Hgb 8.0 or greater
• Creatinine 2 x ULN or less OR GFR greater than 40 ml/min/1.73 m2
• Patient has recovered from last chemotherapy or investigational therapy prior to study enrollment
• Women of child-bearing potential must not be pregnant and take/use effective birth control while participating in the study.