Overview

Surgery in Treating Children With Neuroblastoma

Status:
Completed
Trial end date:
2006-03-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Surgery alone may be effective in treating children with neuroblastoma. PURPOSE: Phase III trial to study the effectiveness of surgery alone in treating children who have neuroblastoma.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Carboplatin
Cyclophosphamide
Doxorubicin
Etoposide
Liposomal doxorubicin
Sargramostim
Criteria
DISEASE CHARACTERISTICS:

- Histologically proven low-risk neuroblastoma (excluding ganglioneuroma)

- International Neuroblastoma Staging System (INSS) stage 1 in all patients

- INSS stage 2A or 2B in patients less than 365 days of age

- INSS stage 2A or 2B tumor with nonamplified MYCN with any Shimada histology in
patients ages 1 to 20 years

- INSS stage 2A or 2B tumor with amplified MYCN with Shimada favorable histology in
patients ages 1 to 20 years

- INSS stage 4S tumors with nonamplified MYCN, Shimada favorable histology, and a
DNA index not equal to 1 in patients less than 365 days of age

- Immediate chemotherapy allowed prior to biopsy for patients with intradural extension
and/or emergent paresis if biopsy performed within 96 hours

- Must have no abnormal organ function unless due to neuroblastoma

- Concurrent registration on companion biology study (protocol COG-ANBL00B1) or its
successor

PATIENT CHARACTERISTICS:

Age:

- Under 21

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin less than 1.5 times normal

- SGOT or SGPT less than 2.5 times normal

Renal:

- Creatinine less than 1.5 times normal

Cardiovascular:

- Shortening fraction greater than 27% by echocardiogram OR

- Ejection fraction greater than 47% by radionuclide angiogram

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunotherapy

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- No prior hormonal therapy

Radiotherapy:

- No prior radiotherapy

Surgery:

- Prior surgery allowed

Other:

- No other prior therapy