Combination Chemotherapy in Treating Young Patients Who Are Undergoing Surgery and an Autologous Bone Marrow Transplant for Disseminated Neuroblastoma

August 1, 2013 updated by: Children's Cancer and Leukaemia Group

Comparison of High Dose Rapid Schedule With Conventional Schedule Chemotherapy for Stage 4 Neuroblastoma Over the Age of One Year

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 more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. A bone marrow transplant, using bone marrow from the patient, may be able to replace blood-forming cells that were destroyed by chemotherapy. It is not yet know which combination chemotherapy schedule is more effective, when given before surgery and an autologous bone marrow transplant, in treating patients with disseminated neuroblastoma.

PURPOSE: This randomized phase III trial is studying two different chemotherapy schedules to compare how well they work in treating young patients who are undergoing surgery and an autologous bone marrow transplant for disseminated neuroblastoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the response rates (bone marrow and primary tumor) in young patients with disseminated neuroblastoma treated with two different combination chemotherapy schedules comprising vincristine, cyclophosphamide, cisplatin, etoposide, and carboplatin followed by surgery and autologous stem cell transplantation.
  • Compare the event-free survival of patients treated with these regimens.
  • Compare the prognostic factors of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (OPEC/OJEC): Patients receive OPEC combination chemotherapy comprising vincristine IV, cyclophosphamide IV, cisplatin IV continuously over 24 hours, and etoposide IV over 4 hours on day 1 of course 1. Patients then receive OJEC combination chemotherapy comprising vincristine IV, cyclophosphamide IV, etoposide IV over 4 hours, and carboplatin IV over 1 hour on day 1 of course 2. OPEC and OJEC regimens alternate so that patients receive 4 courses of OPEC and 3 courses of OJEC over 18 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II (Rapid COJEC): Patients receive vincristine IV and carboplatin IV over 1 hour on day 1 and etoposide IV over 4 hours on days 1 and 2 (regimen 1). Ten days later, patients receive vincristine IV followed by cisplatin IV continuously over 24 hours on day 1 (regimen 2). Ten days later, patients receive vincristine IV on day 1 and etoposide IV over 4 hours and cyclophosphamide IV on days 1 and 2 (regimen 3). Treatment continues for 10 weeks (with a 10-day interval between regimens in this order: regimen 2, regimen 1, regimen 2, regimen 3, and regimen 2) in the absence of disease progression or unacceptable toxicity.

Patients who achieve bone marrow complete remission then undergo surgery. Patients achieving bone marrow partial remission or less are removed from study.

After surgery, patients receive cyclophosphamide IV on day -7 and undergo bone marrow harvest on day 1. Patients then receive high-dose melphalan IV on day 1. Autologous bone marrow cells are reinfused on day 3.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 190 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed disseminated neuroblastoma

    • No local or regional neuroblastoma
    • No disseminated disease that is demonstrated by meta-iodobenzylguanidine (MIBG) scan only

  • Needle biopsy of primary tumor required

    • Fine needle aspiration is not adequate

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy
  • No other prior therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Cancer and Leukaemia Group

Investigators

  • Charles Ross Pinkerton, MD, Royal Marsden NHS Foundation Trust
  • Study Chair: Andrew David J. Pearson, MD, FRCP, DCh, University of Newcastle Upon-Tyne
  • Ian J. Lewis, MD, Leeds Cancer Centre at St. James's University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

August 16, 2006

First Submitted That Met QC Criteria

August 16, 2006

First Posted (Estimate)

August 17, 2006

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCLG-ENSG-5
  • CDR0000454576 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20592
  • CCLG-NB-1990-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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