Overview

This trial is active, not recruiting.

Condition neuroblastoma
Treatments beta-glucan, monoclonal antibody 3f8, immunohistochemistry staining method, laboratory biomarker analysis
Phase phase 1
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator National Cancer Institute (NCI)
Start date August 2005
End date August 2017
Trial size 45 participants
Trial identifier NCT00492167, 05-073, MSKCC-05073

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
beta-glucan
monoclonal antibody 3f8
immunohistochemistry staining method
laboratory biomarker analysis

Primary Outcomes

Measure
Toxicity
time frame: 2 years

Eligibility Criteria

Male or female participants up to 120 years old.

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)

Additional Information

Official title Phase I Study of Oral Yeast β-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma
Principal investigator Brian H. Kushner, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.