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Treatment for Infants and Children With Intermediate Risk Neuroblastoma: A Phase III Intergroup CCG/POG Study

Phase 3
20 Years
Not Enrolling

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Trial Information

Treatment for Infants and Children With Intermediate Risk Neuroblastoma: A Phase III Intergroup CCG/POG Study


- Determine whether the use of selected prognostic variables to assign treatment
increases the event-free survival and overall survival in children with
intermediate-risk neuroblastoma.

- Determine the acute and long-term morbidity and toxicity of surgery and combination
chemotherapy in this patient population.

- Assess the relationship between extent of tumor resection and event-free and overall
survival in patients treated with this regimen.

OUTLINE: Patients receive carboplatin IV over 1 hour on days 0, 21, and 63; cyclophosphamide
IV over 1 hour on days 21 and 42; doxorubicin IV over 15-60 minutes on days 21 and 63; and
etoposide IV over 2 hours on days 0-2, 42-44, and 63-65. Patients under 60 days of age also
receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 hours after
the last chemotherapy administration and continuing until blood counts recover. Patients
with favorable biology who do not achieve complete remission then undergo surgery to remove
or debulk residual disease on day 84 or when blood counts recover. Patients with favorable
biology who achieve partial response and surgery to the primary site is not deemed in the
best interest of the patient may receive additional chemotherapy (as below) and delay
surgery to the primary site after completion of chemotherapy.

Patients with unfavorable biology receive additional chemotherapy comprising
cyclophosphamide IV over 1 hour on days 84, 105, and 147; etoposide IV over 2 hours on days
84-86 and 126-128; carboplatin IV over 1 hour on days 105 and 126; and doxorubicin IV over
15-60 minutes on days 105 and 147. Patients then undergo debulking surgery on day 168 or
when blood counts recover.

Some patients may then undergo radiotherapy after surgery.

Patients are followed monthly for 6 months, every 2 months for 6 months, every 3 months for
1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Inclusion Criteria


- Histologically proven neuroblastoma or maturing ganglioneuroma that is judged to be
intermediate risk by one of the following criteria:

- International Neuroblastoma Staging System (INSS) stage III

- Under 1 year old, MYCN oncogene nonamplified, and any ploidy

- 1 to 20 years old, MYCN nonamplified, favorable Shimada histology

- INSS stage IV

- Under 1 year old, MYCN nonamplified, any ploidy

- INSS stage IVS

- Under 1 year old, MYCN nonamplified, unfavorable Shimada histology and any
ploidy OR favorable Shimada histology and diploidy

- All patients must be registered on the companion neuroblastoma biology study



- Under 21

Performance status:

- Not specified

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


- No abnormal organ function that would prohibit chemotherapy unless due to


Biologic therapy:

- Not specified


- Prior chemotherapy for patients with intradural extension and emergent paresis
allowed provided biopsy was performed within 96 hours after treatment

Endocrine therapy:

- Not specified


- Not specified


- Not specified


- No other prior therapy

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

David L. Baker, MD, MBBS, FRACP, FRCPA

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital for Children


United States: Federal Government

Study ID:




Start Date:

January 1988

Completion Date:

Related Keywords:

  • Neuroblastoma
  • regional neuroblastoma
  • disseminated neuroblastoma
  • stage 4S neuroblastoma
  • localized unresectable neuroblastoma
  • Neuroblastoma



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