High-Risk Neuroblastoma Chemotherapy Without G-CSF
Status:
Completed
Trial end date:
2019-02-05
Target enrollment:
Participant gender:
Summary
Patients will be asked to participate in this study because patients have been diagnosed with
high-risk neuroblastoma, a common childhood cancer which has aggressive features. If left
untreated, high-risk neuroblastoma is fatal. Children with high-risk neuroblastoma often
respond to current available treatments, but there is a high risk that the cancer will
return.
This study will test the safety of giving standard induction treatment for high-risk
neuroblastoma without one of the drugs commonly used to prevent side effects. Current
treatment for high-risk neuroblastoma includes anti-cancer drugs (chemotherapy), surgery,
radiation therapy and high-dose chemotherapy with hematopoietic stem cell rescue. Treatment
takes about one year to complete and occurs in 3 phases: induction, consolidation, and
maintenance. This study is limited to the induction phase of treatment.
Induction therapy includes six chemotherapy drugs given in different combinations every 3
weeks for a total of 6 courses. For the past decade, induction chemotherapy has been followed
by a drug called granulocyte colony stimulating factor (G-CSF, filgrastim, peg-filgrastim,
Neupogen, or Neulasta) to prevent side effects from the chemotherapy. G-CSF is routinely
given to patients with high risk neuroblastoma after chemotherapy to stimulate white blood
cell production and shorten the time period when the absolute neutrophil count (ANC), a type
of white blood cell, is low after chemotherapy. G-CSF is known to shorten the period of low
ANC by approximately 3 days. When the ANC is lowest, a patient is most at risk of getting a
bacterial infection.
Recent lab experiments in mice have shown that neuroblastoma tumor cells may respond to G-CSF
by growing faster and metastasizing (spreading to other parts of the body). There have been
no clinical trials comparing the survival of children with high risk neuroblastoma with or
without G-CSF. This clinical trial is the first step towards giving induction chemotherapy
with less G-CSF.
The goal of this study is to determine if it is safe to give induction chemotherapy to
children with neuroblastoma without giving G-CSF routinely.