Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

Summary

RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or by killing them. It also prepares the patient's bone marrow for the stem cell transplant. The stem cells are given to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving isotretinoin after transplant may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given before a stem cell transplant and isotretinoin in treating neuroblastoma.

PURPOSE: This randomized clinical trial is studying two different combination chemotherapy regimens to compare how well they work when given before a stem cell transplant and isotretinoin in treating young patients with high-risk neuroblastoma.

Conditions

• Neuroblastoma

Interventions

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

PROCEDURE

autologous hematopoietic stem cell transplantation

RADIATION

iobenguane I 131

RADIATION

radiation therapy

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

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-01-31

Primary Completion

2016-12-31

Countries

• Germany
• Switzerland

Study Locations