Beta-Glucan in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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.
|Lung Cancer||Biological: beta-glucan MM-10-001 Other: flow cytometry Other: laboratory biomarker analysis Other: questionnaire administration||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of MM-10-001 In Advanced Non Small Lung Cancer|
- 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 ]
|Study Start Date:||November 2008|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (beta-glucan MM-10-001)
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.
Biological: beta-glucan MM-10-001
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/dayOther: flow cytometry
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.Other: laboratory biomarker analysis
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.Other: questionnaire administration
Assessment pre-study and week 5, week 9, week 13 and at off study.
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857025
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Marianna Koczywas, MD||City of Hope Comprehensive Cancer Center|