Status:
UNKNOWN
Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma Who Are Undergoing Surgery With or Without Autologous Bone Marrow or Peripheral Stem Cell Transplant
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Neuroblastoma
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE3
Brief 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 ch...
Detailed Description
OBJECTIVES: Primary * Determine the outcome, in terms of survival and morbidity, in infants with localized, unresectable, non-MYCN-amplified neuroblastoma treated with reduced-intensity chemotherapy...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed neuroblastoma or ganglioblastoma
- Newly diagnosed disease
- MYCN status known
- Patients are assigned to different study treatment regimens\* according to the following disease criteria:
- Regimen NB 99.1
- Localized unresectable tumor
- If open surgery is considered too hazardous due to the site of the tumor or condition of the infant, then cytological confirmation is allowed, provided adequate material is obtained for study procedures
- No MYCN amplification (i.e., \< 10 copies)
- No metastatic deposits in the bone marrow
- No MIBG or technetium uptake or radiological bone lesions in the skeleton
- No liver disease by ultrasound
- Regimen NB 99.2
- Stage 4 or 4S with metastases confined to the skin, marrow, nodes, or liver
- No bone involvement by radiographs
- No pleural or lung involvement
- No CNS involvement
- No MYCN amplification (i.e., \< 10 copies)
- Regimen NB 99.3
- Stage 4 disease, metastases must meet ≥ 1 of the following criteria:
- Skeletal bone metastases by plain x-ray or CT scan
- Pleural or lung metastases
- CNS involvement
- No MYCN amplification (i.e., \< 10 copies)
- Regimen NB 99.4
- Stage 2-4 disease
- MYCN amplification (i.e., ≥ 10 copies) NOTE: \*Patients with stage 1 or resectable stage 2 disease with no MYCN amplification ( i.e., \< 10 copies) are not eligible for a study treatment regimen but may be enrolled on the study for observation only
- PATIENT CHARACTERISTICS:
- Not specified
- PRIOR CONCURRENT THERAPY:
- No prior therapy
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00417053
Last Update
August 2 2013
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