Observation, Combination Chemotherapy, Radiation Therapy, and/or Autologous Stem Cell Transplant in Treating Young Patients With Neuroblastoma

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. This may allow more chemotherapy to be given so that more tumor cells are killed. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether observation is more effective than combination chemotherapy, radiation therapy, and/or autologous stem cell transplant in treating neuroblastoma.

PURPOSE: This randomized phase III and phase IV trial is studying observation, combination chemotherapy, radiation therapy, and/or autologous stem cell transplant to compare how well they work in treating young patients with neuroblastoma.

Conditions

• Neuroblastoma

Interventions

PROCEDURE

autologous hematopoietic stem cell transplantation

PROCEDURE

conventional surgery

PROCEDURE

peripheral blood stem cell transplantation

RADIATION

iobenguane I 131

RADIATION

radiation therapy

BIOLOGICAL

filgrastim

DRUG

carboplatin

DRUG

cisplatin

DRUG

cyclophosphamide

DRUG

dacarbazine

DRUG

doxorubicin hydrochloride

DRUG

etoposide phosphate

DRUG

ifosfamide

DRUG

isotretinoin

DRUG

melphalan

DRUG

topotecan hydrochloride

DRUG

vincristine sulfate

DRUG

vindesine

Sponsors & Collaborators

• German Society for Pediatric Oncology and Hematology GPOH gGmbH

  lead OTHER

Principal Investigators

• Frank Berthold, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-10-31

Primary Completion

2010-12-31

Countries

• Germany
• Switzerland

Study Locations