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Beta-Glucan and Monoclonal Antibody 3F8 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: NCT00492167
Recruitment Status : Completed
First Posted : June 27, 2007
Last Update Posted : March 7, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:

RATIONALE: Beta-glucan may stimulate the immune system and stop tumor cells from growing. Monoclonal antibodies, such as 3F8, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving beta-glucan together with monoclonal antibody 3F8 may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan when given together with monoclonal antibody 3F8 in treating patients with metastatic neuroblastoma.


Condition or disease Intervention/treatment Phase
Neuroblastoma Biological: beta-glucan Biological: monoclonal antibody 3F8 Other: immunohistochemistry staining method Other: laboratory biomarker analysis Phase 1

Detailed Description:

OBJECTIVES:

Primary

  • Determine the clinical toxicity of beta-glucan in combination with monoclonal antibody 3F8 in patients with metastatic neuroblastoma.
  • Evaluate the biologic effects of this regimen in these patients.

OUTLINE: This is a dose-escalation study of beta-glucan.

Patients receive oral beta-glucan once daily on days -4 to 12 and monoclonal antibody 3F8 IV over 30-90 minutes on days 1-5 and 8-12. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity and with a human antimouse antibody (HAMA) titer < 1,000 U/mL.

Cohorts of 3-6 patients receive escalating doses of beta-glucan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients undergo urine, bone marrow, and blood sample collection periodically for biological studies. Samples are analyzed for antibody-dependent cellular cytotoxicity, complement-mediated cytotoxicity, and serum HAMA response via immunohistochemistry.

After completion of study treatment, patients are followed periodically.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Oral Yeast β-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma
Actual Study Start Date : September 9, 2005
Actual Primary Completion Date : March 4, 2022
Actual Study Completion Date : March 4, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Beta-Glucan and Monoclonal Antibody 3F8

This is a dose-escalation study of beta-glucan. Patients receive oral beta-glucan once daily on days -4 to 12 and monoclonal antibody 3F8 IV over 30-90 minutes on days 1-5 and 8-12. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity and with a human antimouse antibody (HAMA) titer < 1,000 U/mL.

Cohorts of 3-6 patients receive escalating doses of beta-glucan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients undergo urine, bone marrow, and blood sample collection periodically for biological studies. Samples are analyzed for antibody-dependent cellular cytotoxicity, complement-mediated cytotoxicity, and serum HAMA response via immunohistochemistry.

After completion of study treatment, patients are followed periodica

 Biological: beta-glucan
Biological: monoclonal antibody 3F8
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis


Outcome Measures
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Primary Outcome Measures :
  1. Toxicity [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   0 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of neuroblastoma by 1 of the following methods:

    • Histopathology
    • Bone marrow involvement AND elevated urinary catecholamines

  • High-risk disease, defined by 1 of the following:

    • Stage 4 disease with MYCN amplification (any age) or without MYCN amplification (> 18 months of age)
    • MYCN-amplified stage 3 disease (unresectable and any age)
    • MYCN-amplified stage 4S disease
  • Metastatic disease
  • Tumor progression or persistent disease (at metastatic or primary site) after intensive conventional chemotherapy
  • Must have evaluable (microscopic marrow metastasis, elevated tumor markers, positive MIBG or PET scans) or measurable (CT scan or MRI) disease documented after completion of prior systemic therapy

PATIENT CHARACTERISTICS:

  • Platelet count > 25,000/mm^3
  • ANC > 500/mm^3
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergy to mouse proteins, beta-glucan, mushrooms, or yeast
  • No active life-threatening infections

  • No severe major organ toxicity

    • Concurrent toxicity must be ≤ grade 2 except for the following, which may be grade 3:

      • Myelosuppression
      • Hearing loss
      • Alopecia
      • Anorexia
      • Nausea
      • Hyperbilirubinemia from TPN
      • Anxiety
      • Hypomagnesemia
  • No prior HAMA titer > 1,000 U/mL by ELISA

PRIOR CONCURRENT THERAPY:

  • No concurrent supplemental beta-glucan in food (e.g., bran cereals or mushrooms) or as complementary medicine

  • No other concurrent systemic anticancer medications (e.g., hormonal agents, chemotherapy, investigational agents, or immunotherapy)

    • Concurrent isotretinoin allowed after the second course of study treatment is completed or if the patient develops human antimouse antibody (HAMA)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492167


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
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Study Chair: Shakeel Modak, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Brian H. Kushner, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00492167    
Other Study ID Numbers: 05-073
MSKCC-05073
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: March 7, 2022
Last Verified: March 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
disseminated neuroblastoma
Additional relevant MeSH terms:
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Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs