Study on Tumor Cell Vaccine and Low-Dose Chemotherapy for High-Risk Neuroblastoma in Children

Program Overview

Neuroblastoma is a common childhood cancer that can be very serious. Many children with high-risk neuroblastoma see their cancer return after treatment. This study is testing a new approach for children whose cancer has come back or never went away. The treatment involves giving a series of vaccines made from tumor cells, along with a low-dose chemotherapy pill taken daily. The goal is to help the immune system recognize and attack the cancer cells more effectively. The chemotherapy, called metronomic cytoxan, also works by targeting the blood vessels that help tumors grow and reducing certain cells that help tumors hide from the immune system. The study aims to see if this combination is safe and can help reduce the cancer.

Description

The treatment plan involves several vaccine injections. The first vaccine is given three days after starting the daily chemotherapy pill, cytoxan. The next three vaccines are given about every two weeks. During this time, the child will take the cytoxan pill every day, except on the day of the vaccine and for four days after. After the fourth vaccine, the child's cancer will be evaluated. If there are no serious side effects, they can receive four more vaccines, each three weeks apart. The cancer will be checked again after the sixth and eighth vaccines. If the child completes the study, they will have received eight vaccines, and the last cytoxan dose will be one month after the final vaccine. The study lasts up to 15 years, with treatment in the first year and follow-up in the following years.

The vaccines are given like regular vaccines, just under the skin, and are a small amount, about 1/10th of a teaspoon.

Before starting treatment, children will have several medical tests, including a physical exam, blood tests, scans of the cancer, and tests of immune function. Girls who can have children will have a pregnancy test.

During and after treatment, before each vaccine, children will have a physical exam, blood tests, and scans to check the cancer. Immune function will be tested, and girls will have another pregnancy test before the fifth vaccine. Blood samples will be taken before each vaccine and at other times to see how the vaccine affects the immune system. The amount of blood taken will be safe for the child's size and health.

Eligibility Criteria

Locations