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Combination Chemotherapy With or Without Filgrastim Before Surgery, High-Dose Chemotherapy, and Radiation Therapy Followed by Isotretinoin With or Without Monoclonal Antibody in Treating Patients With Neuroblastoma

NCT00030719 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2014-06-24

No results posted yet for this study

Summary

RATIONALE: Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining isotretinoin and monoclonal antibodies may kill any remaining tumor cells following surgery. It is not yet known which treatment regimen is more effective in treating neuroblastoma.

PURPOSE: This randomized phase III trial is studying how well combination chemotherapy with or without filgrastim before surgery, high-dose chemotherapy, and radiation therapy followed by isotretinoin with or without monoclonal antibody work in treating patients with neuroblastoma.

Conditions

Interventions

BIOLOGICAL

filgrastim

BIOLOGICAL

monoclonal antibody Ch14.18

DRUG

busulfan

DRUG

carboplatin

DRUG

cyclophosphamide

DRUG

etoposide

DRUG

isotretinoin

DRUG

melphalan

DRUG

vincristine sulfate

PROCEDURE

bone marrow ablation with stem cell support

PROCEDURE

conventional surgery

PROCEDURE

peripheral blood stem cell transplantation

RADIATION

radiation therapy

Sponsors & Collaborators

  • University of Leicester

    lead OTHER

Principal Investigators

  • Ruth Ladenstein, MD · St. Anna Kinderkrebsforschung

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
1 Year
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Ireland
  • Israel
  • Italy
  • Norway
  • Portugal
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00030719 on ClinicalTrials.gov