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Beta-Glucan in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:
A Phase I Study of MM-10-001 In Advanced Non Small Lung Cancer

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00857025
Study type Interventional
Source City of Hope Medical Center
Contact
Status Completed
Phase Phase 1
Start date November 21, 2008
Completion date May 18, 2021
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