Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Children With Neuroblastoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	Under 21	NCI	COG-A3961 CCG-A3961, POG-A3961, NCT00003093, A3961

Objectives

1. 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.
2. Determine the acute and long-term morbidity and toxicity of surgery and combination chemotherapy in this patient population.
3. Assess the relationship between extent of tumor resection and event-free and overall survival in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• 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 (COG-ANBL00B1)

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

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

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No other prior therapy

Patient Characteristics:

Age:

• Under 21

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No abnormal organ function that would prohibit chemotherapy unless due to neuroblastoma

Expected Enrollment

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

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.

Baker DL, Schmidt M, Cohn S, et al.: A phase III trial of biologically-based therapy reduction for intermediate risk neuroblastoma. [Abstract] J Clin Oncol 25 (Suppl 18): A-9504, 2007.

Attiyeh EF, Mosse YP, Diskin S, et al.: Identification of genomic DNA signatures predicting relapse in low- and intermediate- risk neuroblastoma using a case control design and high-density SNP genotyping: a Children's Oncology Group (COG) study. [Abstract] J Clin Oncol 25 (Suppl 18): A-9500, 526s, 2007.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

David Baker, MD, MBBS, FRACP, FRCPA, Protocol chair		Ph: 61-8-9340-8234

Registry Information
Official Title		Treatment for Infants and Children with Intermediate Risk Neuroblastoma: A Phase III Intergroup CCG/POG Study
Trial Start Date		1988-01-15
Registered in ClinicalTrials.gov		NCT00003093
Date Submitted to PDQ		1997-09-26
Information Last Verified		2005-11-02
NCI Grant/Contract Number		CA13539

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