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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00567567 |
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 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known which regimen of myeloablation chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.
PURPOSE: This randomized phase III trial is comparing two different myeloablation therapies followed by a stem cell transplant in treating young patients with high-risk neuroblastoma.
Condition | Intervention | Phase |
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Neuroblastoma |
Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Drug: melphalan Drug: thiotepa |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma |
Estimated Enrollment: | 495 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Consolidation therapy arm A: Active Comparator
(Single myeloablative consolidation): Patients receive melphalan IV over 15-30 minutes on days -7 to -5, etoposide IV over 24 hours and carboplatin IV over 24 hours on days -7 to -4.
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Drug: carboplatin
Given IV
Drug: etoposide
Given IV
Drug: melphalan
Given IV
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Consolidation therapy arm B: Experimental
(Tandem myeloablative consolidation): Patients receive thiotepa IV over 2 hours on days -7 to -5, cyclophosphamide IV over 1 hour on days -5 to -2. Following recover from this therapy, patients also receive melphalan, etoposide, and carboplatin as in arm A.
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Drug: carboplatin
Given IV
Drug: cyclophosphamide
Given IV
Drug: etoposide
Given IV
Drug: melphalan
Given IV
Drug: thiotepa
Given IV
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Ages Eligible for Study: | up to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of neuroblastoma or ganglioneuroblastoma by histology or as evidenced by the presence of clumps of tumor cells in bone marrow and elevated catecholamine metabolites in urine meeting any of the following criteria:
Patients with newly diagnosed neuroblastoma with International Neuroblastoma Staging System (INSS) stage 4 disease are eligible with the following:
Patients with newly diagnosed neuroblastoma with INSS stage 3 are eligible with the following:
Patients ≥ 365 days initially diagnosed with INSS stage 1, 2, or 4S and who progressed to a stage 4 without interval chemotherapy
PATIENT CHARACTERISTICS:
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70mL/min OR serum creatinine based on age/gender as follows:
PRIOR CONCURRENT THERAPY:
Study Chair: | Julie R. Park, MD | Children's Hospital and Regional Medical Center, Seattle |
Study ID Numbers: | CDR0000576571, COG-ANBL0532 |
Study First Received: | December 4, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00567567 |
Health Authority: | Unspecified |
disseminated neuroblastoma localized resectable neuroblastoma localized unresectable neuroblastoma |
recurrent neuroblastoma regional neuroblastoma stage 4S neuroblastoma |
Melphalan Neuroectodermal Tumors, Primitive Carboplatin Cyclophosphamide Etoposide phosphate Neuroblastoma Recurrence |
Thiotepa Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Etoposide Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antirheumatic Agents Alkylating Agents |