Clinical trial · Interventional
Beta-Glucan in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase I Study of MM-10-001 In Advanced Non Small Lung Cancer
NCT00857025CI-TRIAL-00053195completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| beta-glucan MM-10-001 | Biological | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (beta-glucan MM-10-001)
- description
- Patients receive oral beta-glucan MM-10-001 once or twice daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: beta-glucan MM-10-001
- Other: flow cytometry
- Other: laboratory biomarker analysis
- Other: questionnaire administration
Primary outcomes (3)
- measure
- Safety
- timeFrame
- 28 days after therapy begins
- measure
- Maximum-tolerated dose
- timeFrame
- 28 days after therapy begins
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.