NCT00037011

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

3.2 years

First QC Date

May 13, 2002

Last Update Submit

January 17, 2013

Conditions

Neuroblastoma

Keywords

disseminated neuroblastomarecurrent neuroblastoma

Interventions

beta-glucanBIOLOGICAL
monoclonal antibody 3F8BIOLOGICAL

Eligibility Criteria

AgeUp to 49 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

beta-Glucanshumanized 3F8 anti-GD2 monoclonal antibody

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

GlucansPolysaccharidesCarbohydrates

Study Officials

  • Nai-Kong V. Cheung, MD, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 13, 2002

First Posted

January 27, 2003

Study Start

November 1, 2001

Primary Completion

January 1, 2005

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

US(1)