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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00492167 |
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 | Intervention | Phase |
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Neuroblastoma |
Drug: beta-glucan Drug: monoclonal antibody 3F8 Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Oral Yeast β-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma |
Estimated Enrollment: | 42 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of neuroblastoma by 1 of the following methods:
High-risk disease, defined by 1 of the following:
PATIENT CHARACTERISTICS:
No severe major organ toxicity
Concurrent toxicity must be ≤ grade 2 except for the following, which may be grade 3:
PRIOR CONCURRENT THERAPY:
No other concurrent systemic anticancer medications (e.g., hormonal agents, chemotherapy, investigational agents, or immunotherapy)
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Shakeel Modak, MD 212-639-7623 modaks@mskcc.org |
Study Chair: | Shakeel Modak, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Brian H. Kushner, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000554434, MSKCC-05073 |
Study First Received: | June 25, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00492167 |
Health Authority: | Unspecified |
recurrent neuroblastoma regional neuroblastoma stage 4S neuroblastoma disseminated neuroblastoma |
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 |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Pharmacologic Actions |