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

Inclusion Criteria

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