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| Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004188 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This randomized phase III trial is studying peripheral stem cell transplantation with treated peripheral stem cells following combination chemotherapy to see how well it works compared to peripheral stem cell transplantation with untreated peripheral stem cells following combination chemotherapy in treating patients with neuroblastoma.
| Condition | Intervention | Phase |
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Neuroblastoma |
Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: isotretinoin Drug: melphalan Drug: topotecan hydrochloride Drug: vincristine sulfate Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase III |
| MedlinePlus related topics: | Bone Marrow Transplantation Cancer Neuroblastoma |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized Study of Purged Versus Unpurged Peripheral Blood Stem Cell Transplant Following Dose Intensive Induction Therapy for High Risk Neuroblastoma |
| Study Start Date: | February 2001 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | up to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed neuroblastoma OR ganglioneuroblastoma, and/or evidence of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites, meeting 1 of the following criteria:
Age 12-18 months with stage IV disease meeting one of the following criteria:
At least 1 year old with the following:
Stage I, II, or IVS with disease progression to stage IV without interval chemotherapy
Less than 1 year old with the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other
Contacts and Locations![]() |
Show 96 Study Locations |
| Children's Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Susan G. Kreissman, MD | Duke University |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Kreissman SG, Villablanca JG, Diller L, et al.: Response and toxicity to a dose-intensive multi-agent chemotherapy induction regimen for high risk neuroblastoma (HR-NB): a Children's Oncology Group (COG A3973) study. [Abstract] J Clin Oncol 25 (Suppl 18): A-9505, 527s, 2007.
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| Study ID Numbers: | CDR0000067429, COG-A3973, CCG-A3973, POG-A3973, CCG-39703, FHCRC-1631.00 |
| First Received: | January 21, 2000 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004188 |
| Health Authority: | United States: Federal Government |
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