Protracted Etoposide During Induction Therapy for High Risk Neuroblastoma
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
High-risk neuroblastoma is an aggressive childhood cancer that shows up as a lump or mass in
the belly or around the spinal cord in the chest, neck, or pelvis. Often the tumor has spread
around the body to the bones or to the soft center of the bone, called the bone marrow.
High-risk neuroblastoma often responds to treatment at first, but it frequently comes back
and may be even more difficult to treat.
Chemotherapy (drug treatments for cancer) is usually given at high doses in short bursts (3
to 5 days) followed by a few weeks of rest and recovery. This burst and recovery is called a
"cycle" and usually takes about 21 days. Some scientists and physicians have tried to give
chemotherapy at lower doses for more days, called "metronomic" chemotherapy. This method of
giving chemotherapy has been used to treat neuroblastoma that has failed more standard types
of treatment (relapsed neuroblastoma) and has shown some promise for those patients. One of
the reasons it may work is by killing the blood vessels that feed the tumor as well as
killing tumor cells themselves (the way that burst chemotherapy works). We think that giving
a burst of chemotherapy together with metronomic therapy may kill the tumor while decreasing
the side effects that we have seen in the past.
Treatment for high risk neuroblastoma usually occurs in 3 stages: induction, consolidation,
and maintenance. During the induction phase, patients will receive chemotherapy and possibly
more surgery to get rid of most of the tumor cells. Most of the chemotherapy drugs during
induction will be given in the standard burst method. One of the chemotherapy drugs,
etoposide, will be given in lower, metronomic doses. The doctors will study how the tumors
respond and the side effects patients have. After induction most childrens' tumors will have
disappeared, also called remission. These children will receive the second stage of treatment
called consolidation. During this stage, subjects will receive radiation treatments to the
tumor and then higher doses of chemotherapy. Because of the side effects of the high doses of
chemotherapy, we will collect and store some special blood cells (called hematopoietic stem
cells) early in treatment and keep them frozen. After the high doses of chemotherapy, these
cells will be thawed and given to the subject. . This is called hematopoietic stem cell
transplant (HSCT). The final stage of treatment, called maintenance, consists of a drug taken
by mouth for 6 months.
Surgery to remove large, or bulky, tumors is a standard part of treatment for high risk
neuroblastoma. A few children can have their main tumor removed before chemotherapy, but most
require the tumor to shrink first. Surgery has usually been scheduled for after 3 to 5 cycles
of therapy, but no one really knows how quickly the tumors are ready to come out. Because
chemotherapy has significant side effects that can change the risks of surgery, we will study
how early surgeries to remove tumors can happen.
This study is being done to evaluate the outcomes of disease response and survival in
children with high risk neuroblastoma treated on this regimen.