Beta-Glucan in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Biological: beta-glucan MM-10-001Other: flow cytometryOther: laboratory biomarker analysisOther: questionnaire administration
- Registration Number
- NCT00857025
- Lead Sponsor
- City of Hope Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (beta-glucan MM-10-001) questionnaire administration 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. Treatment (beta-glucan MM-10-001) flow cytometry 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. Treatment (beta-glucan MM-10-001) 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. Treatment (beta-glucan MM-10-001) laboratory biomarker analysis 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.
- Primary Outcome Measures
Name Time Method Safety 28 days after therapy begins Toxicity as assessed by NCI CTCAE v3.0 28 days after therapy begins Maximum-tolerated dose 28 days after therapy begins
- Secondary Outcome Measures
Name Time Method Survival 1 year after start of study Beta-glucan MM-10-001 activity as assessed by changes in natural killer cell activation and functional activity, cytokine profiling, and clinical benefit 13 weeks after start of study treatment Patient-reported functional status 13 weeks after start of study treatment Progression-free survival 1 year after start of study
Trial Locations
- Locations (1)
City of Hope Medical Center
🇺🇸Duarte, California, United States