Lung CancerPhase 1NCT00857025
Beta-Glucan in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 1 study testing beta-glucan MM-10-001, flow cytometry and laboratory biomarker analysis in people with Lung Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- beta-glucan MM-10-001, flow cytometry and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2008to 18 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010-3000
About this study
Official title: A Phase I Study of MM-10-001 In Advanced Non Small 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.
Read the 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 curative or palliative measures do not exist or are no longer effective.
Secondary
- To explore analysis of the effect of beta-glucan MM-10-001 on the innate immune compartment, in particular natural killer cell activation and effector status.
- To perform correlatives (cytokine profiling) that will explore the effects of beta-glucan MM-10-001 on the cytokine profile of these patients.
- To document all clinical responses of these patients after treatment with beta-glucan MM-10-001.
- To explore potential beta-glucan MM-10-001 dose effects on the patient-reported functional status.
OUTLINE: 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.
Blood samples are collected periodically for correlative studies. Samples are analyzed for natural killer cell activation and effector status and cytokine profiling by flow cytometry.
Patient-reported functional status is assessed at baseline and periodically during treatment by QOL-FACT-L questionnaire.
After completion of study treatment, patients are followed periodically.
- Conditions
- Lung Cancer
- Being tested
- beta-glucan MM-10-001, flow cytometry, laboratory biomarker analysis, questionnaire administration
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beta-glucan MM-10-001Biological
Dose escalation with six patients treated at each of the following oral dosages: 2.5, 5.0, 7.5, 10, 15, 20, 30, 40, 50, and 80 mg/day
flow cytometryOther
Performed on blood samples collected within 14 days prior to study treatment and at week 1, week 5, week 9, week 13 and every 4 weeks until the end of study treatment.
laboratory biomarker analysisOther
Performed on blood samples collected within 14 days prior to study treatment and at week 1, week 5, week 9, week 13 and at the end of study treatment.
questionnaire administrationOther
Assessment pre-study and week 5, week 9, week 13 and at off study.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (beta-glucan MM-10-001) | Experimental | 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. Receives: Biological: beta-glucan MM-10-001; Other: flow cytometry; Other: laboratory biomarker analysis; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: 28 days after therapy begins
Maximum-tolerated dose
Measured: 28 days after therapy begins
Toxicity as assessed by NCI CTCAE v3.0
Measured: 28 days after therapy begins
Secondary outcomes (4)
Beta-glucan MM-10-001 activity as assessed by changes in natural killer cell activation and functional activity, cytokine profiling, and clinical benefit
Measured: 13 weeks after start of study treatment
Patient-reported functional status
Measured: 13 weeks after start of study treatment
Survival
Measured: 1 year after start of study
Progression-free survival
Measured: 1 year after start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study start25 Nov 2008
- Primary completion24 Nov 2010
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marianna Koczywas, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857025
- Sponsor's protocol ID
- 07243
- Other IDs
- P30CA033572, CHNMC-07243, CDR0000634737
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2009
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of MM-10-001 In Advanced Non Small Lung Cancer
- ClinicalTrials.gov ID
- NCT00857025
- Acronym / sponsor ID
- 07243
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Nov 2008 (actual)
- Primary completion
- 24 Nov 2010 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 6 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 curative or palliative measures do not exist or are no longer effective.
Secondary
- To explore analysis of the effect of beta-glucan MM-10-001 on the innate immune compartment, in particular natural killer cell activation and effector status.
- To perform correlatives (cytokine profiling) that will explore the effects of beta-glucan MM-10-001 on the cytokine profile of these patients.
- To document all clinical responses of these patients after treatment with beta-glucan MM-10-001.
- To explore potential beta-glucan MM-10-001 dose effects on the patient-reported functional status.
OUTLINE: 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.
Blood samples are collected periodically for correlative studies. Samples are analyzed for natural killer cell activation and effector status and cytokine profiling by flow cytometry.
Patient-reported functional status is assessed at baseline and periodically during treatment by QOL-FACT-L questionnaire.
After completion of study treatment, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (beta-glucan MM-10-001) | Experimental | Biological: beta-glucan MM-10-001, Other: flow cytometry, Other: laboratory biomarker analysis, Other: questionnaire administrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beta-glucan MM-10-001Dose escalation with six patients treated at each of the following oral dosages: 2.5, 5.0, 7.5, 10, 15, 20, 30, 40, 50, and 80 mg/day | Biological | Treatment (beta-glucan MM-10-001) |
| flow cytometryPerformed on blood samples collected within 14 days prior to study treatment and at week 1, week 5, week 9, week 13 and every 4 weeks until the end of study treatment. | Other | Treatment (beta-glucan MM-10-001) |
| laboratory biomarker analysisPerformed on blood samples collected within 14 days prior to study treatment and at week 1, week 5, week 9, week 13 and at the end of study treatment. | Other | Treatment (beta-glucan MM-10-001) |
| questionnaire administrationAssessment pre-study and week 5, week 9, week 13 and at off study. | Other | Treatment (beta-glucan MM-10-001) |
Primary outcome
Safety
Time frame: 28 days after therapy begins
Maximum-tolerated dose
Time frame: 28 days after therapy begins
Toxicity as assessed by NCI CTCAE v3.0
Time frame: 28 days after therapy begins
4 secondary outcomes
Beta-glucan MM-10-001 activity as assessed by changes in natural killer cell activation and functional activity, cytokine profiling, and clinical benefit
Time frame: 13 weeks after start of study treatment
Patient-reported functional status
Time frame: 13 weeks after start of study treatment
Survival
Time frame: 1 year after start of study
Progression-free survival
Time frame: 1 year after start of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianna Koczywas, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing beta-glucan MM-10-001, flow cytometry and laboratory biomarker analysis in people with Lung Cancer, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 28 days after therapy begins). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.