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Completed NCT00857025

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

Conditions: Lung Cancer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 20
Sponsor: City of Hope Medical Center

Location: City of Hope Medical Center Duarte California

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.

Eligibility 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT00857025). StuddyBuddy aggregates publicly available trial information.