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