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

Neuroblastoma Clinical Trial

Official title:

Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037011
• Other study ID #: 01-075
• Secondary ID: P30CA008748MSKCC
• Status: Completed
• Phase: Phase 1
• First received: May 13, 2002
• Last updated: January 17, 2013
• Start date: November 2001

Study information

• Verified date: January 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Biological therapies such as beta-glucan use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining beta-glucan and monoclonal antibody may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining beta-glucan and monoclonal antibody in treating patients who have metastatic neuroblastoma.

Description:

OBJECTIVES:

• Determine the maximum tolerated dose of beta-glucan and monoclonal antibody 3F8 in patients with metastatic neuroblastoma.

• Determine the toxicity of this regimen in these patients.

• Assess the biological effects of this regimen in these patients.

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 49 Years

Eligibility

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

PATIENT CHARACTERISTICS:

Age:

• Under 50

Performance status:

• Not specified

Life expectancy:

• See Disease Characteristics

Hematopoietic:

• Platelet count greater than 25,000/mm^3

• Absolute neutrophil count greater than 500/mm^3

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

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Biological:
• beta-glucan

• monoclonal antibody 3F8

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,