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Beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00037011
  Purpose

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.


Condition Intervention Phase
Neuroblastoma
Drug: beta-glucan
Drug: monoclonal antibody 3F8
Phase I

MedlinePlus related topics: Cancer Neuroblastoma
Drug Information available for: Immunoglobulins Globulin, Immune beta-Glucan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2001
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.

  Eligibility

Ages Eligible for Study:   up to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00037011

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Nai-Kong V. Cheung, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069348, MSKCC-01075, NCI-G02-2067
Study First Received: May 13, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00037011  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
disseminated neuroblastoma
recurrent neuroblastoma

Study placed in the following topic categories:
Antibodies, Monoclonal
Neuroectodermal Tumors
Antibodies
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Neuroectodermal Tumors, Primitive, Peripheral
Recurrence
Neuroblastoma
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009