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

NCT ID: NCT00037011

Last Updated: 2013-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30

Brief 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.

Detailed 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.

Conditions

Neuroblastoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

beta-glucan

Intervention Type: BIOLOGICAL

monoclonal antibody 3F8

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

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

• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Nai-Kong V. Cheung, MD, PhD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

P30CA008748

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MSKCC-01075

Identifier Type: -

Identifier Source: secondary_id

NCI-G02-2067

Identifier Type: -

Identifier Source: secondary_id

01-075

Identifier Type: -

Identifier Source: org_study_id