Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
NCT00004188 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 495
Last updated 2013-05-17
Summary
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.
Conditions
Interventions
- BIOLOGICAL
-
Given IV
- DRUG
-
Given IV
- DRUG
-
Given IV
- DRUG
-
Given IV
- DRUG
-
doxorubicin hydrochloride
Given IV
- DRUG
-
etoposide
Given IV
- DRUG
-
isotretinoin
Given IV
- DRUG
-
melphalan
Given IV
- DRUG
-
topotecan hydrochloride
Given IV
- DRUG
-
vincristine sulfate
Given IV
- PROCEDURE
-
autologous bone marrow transplantation
- PROCEDURE
-
bone marrow ablation with stem cell support
- PROCEDURE
-
conventional surgery
All patients undergo delayed surgical resection of the residual tumor after course 5 of induction chemotherapy
- PROCEDURE
-
peripheral blood stem cell transplantation
- RADIATION
-
radiation therapy
After completion of consolidation (at least 28 days from stem cell infusion), all patients receive local radiotherapy daily over 7 days
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Children's Oncology Group
lead NETWORK
Principal Investigators
-
Susan G. Kreissman, MD · Duke Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-02-28
- Primary Completion
- 2007-10-31
Countries
- United States
- Canada
Study Locations
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