CompletedPhase 1NCT00857025

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

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.

Checked against the public recordLast updated Aug 10, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations1
SponsorCity of Hope Medical Center
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
City of Hope Medical Center
Interventions being studied
Biological: beta-glucan MM-10-001; Other: flow cytometry; Other: laboratory biomarker analysis; Other: questionnaire administration
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • City of Hope Medical CenterDuarte, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 10, 2021. Always confirm current availability with the study team.

View original record ↗