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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00037011
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 18, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE May 13, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date January 18, 2013
Study Start Date  ICMJE November 2001
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma
Official Title  ICMJE Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Neuroblastoma
Intervention  ICMJE
  • Biological: beta-glucan
  • Biological: monoclonal antibody 3F8
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 49 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00037011
Other Study ID Numbers  ICMJE 01-075
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-01075
NCI-G02-2067
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Nai-Kong V. Cheung, MD, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date January 2013

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