A Phase I Study of MM-10-001 In Advanced Non Small Lung Cancer
- To assess the feasibility and toxicity of therapy with beta-glucan MM-10-001 in
patients with locally advanced or metastatic non-small cell lung cancer for which
standard curative or palliative measures do not exist or are no longer effective.
- To explore analysis of the effect of beta-glucan MM-10-001 on the innate immune
compartment, in particular natural killer cell activation and effector status.
- To perform correlatives (cytokine profiling) that will explore the effects of
beta-glucan MM-10-001 on the cytokine profile of these patients.
- To document all clinical responses of these patients after treatment with beta-glucan
- To explore potential beta-glucan MM-10-001 dose effects on the patient-reported
OUTLINE: Patients receive oral beta-glucan MM-10-001 once or twice daily. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for correlative studies. Samples are analyzed for
natural killer cell activation and effector status and cytokine profiling by flow cytometry.
Patient-reported functional status is assessed at baseline and periodically during treatment
by QOL-FACT-L questionnaire.
After completion of study treatment, patients are followed periodically.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
28 days after therapy begins
Marianna Koczywas, MD
Beckman Research Institute
United States: Food and Drug Administration
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|