Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	Under 50	NCI	MSKCC-01075 NCI-G02-2067, NCT00037011

Objectives

1. Determine the maximum tolerated dose of beta-glucan and monoclonal antibody 3F8 in patients with metastatic neuroblastoma.
2. Determine the toxicity of this regimen in these patients.
3. Assess the biological effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed high-risk stage 4 metastatic neuroblastoma
  • May be confirmed by bone marrow involvement and elevated urinary catecholamines



• Progressive or persistent disease after intensive conventional chemotherapy that included induction with N6, N7, N8, or COG protocol with or without bone marrow or stem cell transplantation



• Poor long-term prognosis as defined by any of the following:
  • N-myc amplification in tumor cells
  • Diploid chromosomal content plus 1p loss of heterozygosity in tumor cells
  • Distant skeletal metastases
  • Unresectable primary tumor infiltrating across the midline
  • More than 10% tumor cells in bone marrow



• Measurable or evaluable disease documented at least 4 weeks after completion of prior systemic therapy

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics
• No prior exposure to mouse antibodies and human anti-mouse antibody greater than 1,000 ELISA units/mL

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No other concurrent supplemental beta-glucan either as food (e.g., bran cereals) or as complementary medicine

Patient Characteristics:

Age:

• Under 50

Performance status:

• Not specified

Life expectancy:

• See Disease Characteristics

Hematopoietic:

• Platelet count greater than 25,000/mm³
• Absolute neutrophil count greater than 500/mm³

Hepatic:

• Not specified

Renal:

• Creatinine clearance greater than 60 mL/min

Other:

• No severe major organ toxicity
• No active life-threatening infections
• No prior allergy to mouse proteins
• No prior allergy to beta-glucan, oats, barley, mushrooms, or yeast
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A maximum of 24 patients will be accrued for this study within 2 years.

Outline

This is a dose-escalation study.

Patients receive oral beta-glucan and monoclonal antibody 3F8 (MOAB 3F8) IV within 1.5 hours on days 1-5 and 8-12. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of beta-glucan and MOAB 3F8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Patients are followed monthly for 6 months, every 2 months for 6 months, and then every 3-6 months for 2 years.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Nai-Kong Cheung, MD, PhD, Protocol chair		Ph: 212-639-8401; 800-525-2225

Registry Information
Official Title		Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients with Metastatic Neuroblastoma
Trial Start Date		2001-11-27
Registered in ClinicalTrials.gov		NCT00037011
Date Submitted to PDQ		2002-03-26
Information Last Verified		2004-09-08
NCI Grant/Contract Number		P30-CA08748

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