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

You may be eligible if

• DISEASE CHARACTERISTICS:
• Pathologically confirmed non-small cell lung cancer
• * Locally advanced or metastatic disease for which standard curative or palliative measures do not exist or are no longer effective
• * Unresectable disease
• 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:
• * GI tract disease
• * No intractable nausea or vomiting
• * Malabsorption syndrome
• * Requirement for IV alimentation
• * Prior surgical procedures effecting absorption
• * Uncontrolled inflammatory GI disease (e.g., Crohn disease, ulcerative colitis)
• 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:
• * Ongoing or active infection
• * Symptomatic congestive heart failure
• * Unstable angina pectoris
• * Cardiac arrhythmia
• * Psychiatric illness or social situation that would limit compliance with study requirements
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy and recovered
• * Concurrent palliative radiotherapy for symptoms control allowed
• 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
• * Bisphosphonate therapy (e.g., pamidronate or zoledronate) allowed
• 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