High-Risk Neuroblastoma Chemotherapy Without G-CSF

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.

Conditions

• Neuroblastoma

Interventions

DRUG

Topotecan

CYCLE 1+2 (given by intravenous catheter daily for 5 days)

DRUG

Cyclophosphamide

CYCLE 1+2 (given by intravenous catheter daily for 5 days)

DRUG

Cisplatin

Cycle 3+5 (given daily x 4 days)

DRUG

Etoposide

Cycle 3+5 (given daily for 3 days)

DRUG

Vincristine

Cycle 4+6 (given daily for 3 days)

DRUG

Cyclophosphamide

Cycle 4+6 (given daily for 2 days)

DRUG

Doxorubicin

Cycle 4+6 (given daily for 3 days)

DRUG

Sargramostim

Granulocyte macrophage colony stimulating factor (rhu GM-CSF, rGM-CSF, GM-CSF)

Sponsors & Collaborators

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Sarah Whittle, MD, BA · Baylor College of Medicine

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Months

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2019-02-05

Completion

2019-02-05

Countries

• United States

Study Locations