Trial Information

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

OBJECTIVES:

- 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.