Phase I Study of Oral Yeast β-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Shakeel Modak, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|