RATIONALE: Biological therapies, such as beta-glucan, may stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan in treating patients with locally advanced or metastatic non-small cell lung cancer.
OBJECTIVES: Primary * 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. Secondary * 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 MM-10-001. * To explore potential beta-glucan MM-10-001 dose effects on the patient-reported functional status. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Dose escalation with six patients treated at each of the following oral dosages: 2.5, 5.0, 7.5, 10, 15, 20, 30, 40, 50, and 80 mg/day
Performed on blood samples collected within 14 days prior to study treatment and at week 1, week 5, week 9, week 13 and every 4 weeks until the end of study treatment.
Performed on blood samples collected within 14 days prior to study treatment and at week 1, week 5, week 9, week 13 and at the end of study treatment.
City of Hope Medical Center
Duarte, California, United States
Safety
Time frame: 28 days after therapy begins
Maximum-tolerated dose
Time frame: 28 days after therapy begins
Toxicity as assessed by NCI CTCAE v3.0
Time frame: 28 days after therapy begins
Beta-glucan MM-10-001 activity as assessed by changes in natural killer cell activation and functional activity, cytokine profiling, and clinical benefit
Time frame: 13 weeks after start of study treatment
Patient-reported functional status
Time frame: 13 weeks after start of study treatment
Survival
Time frame: 1 year after start of study
Progression-free survival
Time frame: 1 year after start of study
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Assessment pre-study and week 5, week 9, week 13 and at off study.