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A Phase I Study of MM-10-001 In Advanced Non Small Lung Cancer

Phase 1
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

A Phase I Study of MM-10-001 In Advanced Non Small Lung Cancer



- 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.


- 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

- 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.

Inclusion Criteria


- 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


- 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

- 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

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situation that would limit compliance with study


- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

28 days after therapy begins

Safety Issue:


Principal Investigator

Marianna Koczywas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



City of Hope Comprehensive Cancer CenterDuarte, California  91010