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Beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma
This study is ongoing, but not recruiting participants.
Study NCT00037011   Information provided by National Cancer Institute (NCI)
First Received: May 13, 2002   Last Updated: February 6, 2009   History of Changes

May 13, 2002
February 6, 2009
November 2001
 
 
 
Complete list of historical versions of study NCT00037011 on ClinicalTrials.gov Archive Site
 
 
 
Beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma
Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma

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.

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.

Phase I
Interventional
Treatment
Neuroblastoma
  • Biological: beta-glucan
  • Biological: monoclonal antibody 3F8
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
up to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00037011
 
CDR0000069348, MSKCC-01075, NCI-G02-2067
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Nai-Kong V. Cheung, MD, PhD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
September 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP