Beta-Glucan and Monoclonal Antibody 3F8 in Treating Patients With Metastatic Neuroblastoma

NCT00492167 | Completed Phase 1

• 2 other identifiers: 05-073MSKCC-05073
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroblastoma

Keywords

recurrent neuroblastoma; regional neuroblastoma; stage 4S neuroblastoma; disseminated neuroblastoma

Outcome Measures

Primary Outcomes (1)

• Toxicity

  2 years

Study Arms (1)

Beta-Glucan and Monoclonal Antibody 3F8

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

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

Interventions

beta-glucan BIOLOGICAL

Beta-Glucan and Monoclonal Antibody 3F8

monoclonal antibody 3F8 BIOLOGICAL

Beta-Glucan and Monoclonal Antibody 3F8

immunohistochemistry staining method OTHER

Beta-Glucan and Monoclonal Antibody 3F8

laboratory biomarker analysis OTHER

Beta-Glucan and Monoclonal Antibody 3F8

Eligibility Criteria

• Age: 0 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Cardenas FI, Mauguen A, Cheung IY, Kramer K, Kushner BH, Ragupathi G, Cheung NV, Modak S. Phase I Trial of Oral Yeast-Derived beta-Glucan to Enhance Anti-GD2 Immunotherapy of Resistant High-Risk Neuroblastoma. Cancers (Basel). 2021 Dec 14;13(24):6265. doi: 10.3390/cancers13246265.

  PMID: 34944886 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Neuroblastoma

Interventions

beta-Glucans; humanized 3F8 anti-GD2 monoclonal antibody; Immunohistochemistry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Shakeel Modak, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

• Brian H. Kushner, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 27, 2007
• Study Start: September 9, 2005
• Primary Completion: March 4, 2022
• Study Completion: March 4, 2022
• Last Updated: March 7, 2022

Record last verified: 2022-03

Locations

US (1)