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About
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.
Full description
OBJECTIVES:
Primary
Secondary
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.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Pathologically confirmed non-small cell lung cancer
No active or symptomatic brain metastases unless they were previously treated by radiotherapy or surgery, stabilized, AND off steroid therapy for ≥ 4 weeks
PATIENT CHARACTERISTICS:
Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
Life expectancy > 3 months
WBC > 2,000/mm³
Absolute neutrophil count > 1,000/mm³
Platelet count > 50,000/mm³
Total bilirubin < 1.5 times upper limit of normal (ULN)
AST and ALT < 2.5 times ULN
Serum creatinine < 2.5 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Must be able to swallow enteral medications (patients with feeding tubes are eligible)
No condition or disease that affects gastrointestinal (GI) function or impairs the ability to take oral medications including any of the following:
No concurrent condition requiring the use of systemic or topical steroids or the use of immunosuppressive agents
No history of allergic reactions attributed to compounds of similar chemical or biological composition to beta-glucan MM-10-001
No uncontrolled concurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy and recovered
At least 2 weeks since prior corticosteroids and no concurrent systemic or topical steroids
At least 7 days since prior antioxidant supplements (vitamin C and E)
No other concurrent investigational agents
No concurrent over-the-counter or dietary supplement containing beta-glucan (e.g., mushroom extracts, "lentinan" products, dried mushrooms) or other mushroom-derived powders, liquids, capsules, gels, or any other dosage form
No concurrent use of immunosuppressive agents (e.g., cyclosporine and its analog)
No concurrent darbepoetin alfa or epoetin alfa
No concurrent colony-stimulating factors
No concurrent antiretroviral therapy for HIV-positive patients
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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