Beta-Glucan in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00857025
First received: March 5, 2009
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Biological: beta-glucan MM-10-001
Other: flow cytometry
Other: laboratory biomarker analysis
Other: questionnaire administration
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of MM-10-001 In Advanced Non Small Lung Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Safety [ Time Frame: 28 days after therapy begins ] [ Designated as safety issue: Yes ]
  • Maximum-tolerated dose [ Time Frame: 28 days after therapy begins ] [ Designated as safety issue: Yes ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: 28 days after therapy begins ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Patient-reported functional status [ Time Frame: 13 weeks after start of study treatment ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 1 year after start of study ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 1 year after start of study ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2008
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (beta-glucan MM-10-001)
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.
Biological: beta-glucan MM-10-001
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
Other: flow cytometry
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.
Other: laboratory biomarker analysis
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.
Other: questionnaire administration
Assessment pre-study and week 5, week 9, week 13 and at off study.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857025

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Marianna Koczywas, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00857025     History of Changes
Other Study ID Numbers: 07243, P30CA033572, CHNMC-07243, CDR0000634737
Study First Received: March 5, 2009
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014