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

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer Read More

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