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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00365755
First received: August 16, 2006
Last updated: August 1, 2013
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Neuroblastoma
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: melphalan
Drug: vincristine sulfate
Procedure: autologous bone marrow transplantation
Procedure: conventional surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Comparison of High Dose Rapid Schedule With Conventional Schedule Chemotherapy for Stage 4 Neuroblastoma Over the Age of One Year

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Completion Date: March 2008
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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00365755

Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Investigator: Charles Ross Pinkerton, MD Royal Marsden NHS Foundation Trust
Study Chair: Andrew David J. Pearson, MD, FRCP, DCh University of Newcastle Upon-Tyne
Investigator: Ian J. Lewis, MD Leeds Cancer Centre at St. James's University Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00365755     History of Changes
Other Study ID Numbers: CCLG-ENSG-5, CDR0000454576, EU-20592, CCLG-NB-1990-11
Study First Received: August 16, 2006
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
disseminated neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Cisplatin
Cyclophosphamide
Etoposide
Melphalan
Vincristine
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014