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Busulfan, Melphalan, and Stem Cell Transplant After Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

NCT01798004 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-07-15

Study results available
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Summary

This pilot clinical trial studies busulfan, melphalan, and stem cell transplant after chemotherapy in treating patients with newly diagnosed neuroblastoma that is likely to come back or spread. Giving chemotherapy to the entire body before a stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Conditions

  • Ganglioneuroblastoma
  • Stage 1 Neuroblastoma
  • Stage 2 Neuroblastoma
  • Stage 2A Neuroblastoma
  • Stage 2B Neuroblastoma
  • Stage 3 Neuroblastoma
  • Stage 4 Neuroblastoma
  • Stage 4S Neuroblastoma

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous peripheral blood stem cell transplant

DRUG

Busulfan

Given IV

DRUG

Cisplatin

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

RADIATION

External Beam Radiation Therapy

Undergo EBRT

BIOLOGICAL

Filgrastim

Given SC or IV

OTHER

Laboratory Biomarker Analysis

Optional correlative studies

DRUG

Melphalan

Given IV

DRUG

Mesna

Given IV

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo autologous peripheral blood stem cell transplant

OTHER

Pharmacological Study

Correlative studies

DRUG

Topotecan Hydrochloride

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Mary Meaghan P Granger · Children's Oncology Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-09
Primary Completion
2015-07-28
Completion
2024-06-30

Countries

  • United States
  • Australia
  • Canada
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01798004 on ClinicalTrials.gov