AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in United States

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 groups in NCT00857025
Study groupRoleWhat they receive
Treatment (beta-glucan MM-10-001)ExperimentalPatients 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.

  1. Safety

    Measured: 28 days after therapy begins

  2. Maximum-tolerated dose

    Measured: 28 days after therapy begins

  3. Toxicity as assessed by NCI CTCAE v3.0

    Measured: 28 days after therapy begins

Secondary outcomes (4)
  1. 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

  2. Patient-reported functional status

    Measured: 13 weeks after start of study treatment

  3. Survival

    Measured: 1 year after start of study

  4. 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.

  1. First posted6 Mar 2009 (estimated)
  2. Study start25 Nov 2008
  3. Primary completion24 Nov 2010
  4. Study completion18 May 2021

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in