Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Children's Cancer and Leukaemia Group |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00365755 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Comparison of High Dose Rapid Schedule With Conventional Schedule Chemotherapy for Stage 4 Neuroblastoma Over the Age of One Year |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 1 Year to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed disseminated neuroblastoma
Needle biopsy of primary tumor required
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Investigator: | Charles Ross Pinkerton, MD | Royal Marsden - Surrey |
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 |
Study ID Numbers: | CDR0000454576, CCLG-ENSG-5, EU-20592, CCLG-NB-1990-11 |
Study First Received: | August 16, 2006 |
Last Updated: | March 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00365755 History of Changes |
Health Authority: | United States: Federal Government |
disseminated neuroblastoma |
Melphalan Neuroectodermal Tumors, Primitive Immunologic Factors Vincristine Antimitotic Agents Cyclophosphamide Carboplatin Immunosuppressive Agents Etoposide phosphate Neuroblastoma Neuroectodermal Tumors |
Cisplatin Neoplasms, Germ Cell and Embryonal Tubulin Modulators Neuroepithelioma Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Etoposide Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors, Primitive Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Cyclophosphamide Neuroblastoma Neoplasms, Germ Cell and Embryonal Therapeutic Uses Alkylating Agents Neoplasms by Histologic Type Mitosis Modulators Vincristine |
Antimitotic Agents Carboplatin Immunosuppressive Agents Pharmacologic Actions Neuroectodermal Tumors Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antirheumatic Agents Antineoplastic Agents, Phytogenic Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |