Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma Who Are Undergoing Surgery With or Without Autologous Bone Marrow or Peripheral Stem Cell Transplant
NCT00417053 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2013-08-02
Summary
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. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known which combination chemotherapy regimen given together with surgery, with or without autologous bone marrow or peripheral stem cell transplant, is more effective in treating newly diagnosed neuroblastoma.
PURPOSE: This phase III trial is studying combination chemotherapy to see which regimen given together with surgery, with or without autologous bone marrow or peripheral stem cell transplant, works in treating infants with newly diagnosed neuroblastoma.
Conditions
Interventions
- DRUG
-
etoposide phosphate
- DRUG
-
melphalan
- 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
- RADIATION
-
radiation therapy
- DRUG
-
doxorubicin hydrochloride
- BIOLOGICAL
- DRUG
-
busulfan
- DRUG
- DRUG
Sponsors & Collaborators
-
Children's Cancer and Leukaemia Group
lead OTHER
Principal Investigators
-
Mary P. Gerrard, MBChB, FRCP, FRCPCH · Children's Hospital - Sheffield
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Max Age
- 1 Year
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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