Status:
COMPLETED
Beta-Glucan in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
OBJECTIVES: Primary * To assess the feasibility and toxicity of therapy with beta-glucan MM-10-001 in patients with locally advanced or metastatic non-small cell lung cancer for which standard curat...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 21 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00857025
Start Date
November 21 2008
End Date
May 18 2021
Last Update
August 10 2021
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010-3000