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

NCT00857025 | Completed Phase 1 DMC

• 4 other identifiers: 07243P30CA033572CHNMC-07243CDR0000634737
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• Safety

  28 days after therapy begins

• Maximum-tolerated dose

  28 days after therapy begins

• Toxicity as assessed by NCI CTCAE v3.0

  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

  13 weeks after start of study treatment

• Patient-reported functional status

  13 weeks after start of study treatment

• Survival

  1 year after start of study

• Progression-free survival

  1 year after start of study

Study Arms (1)

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.

Biological: beta-glucan MM-10-001; Other: flow cytometry; Other: laboratory biomarker analysis; Other: questionnaire administration

Interventions

beta-glucan MM-10-001 BIOLOGICAL

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

Treatment (beta-glucan MM-10-001)

flow cytometry OTHER

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.

Treatment (beta-glucan MM-10-001)

laboratory biomarker analysis OTHER

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.

Treatment (beta-glucan MM-10-001)

questionnaire administration OTHER

Assessment pre-study and week 5, week 9, week 13 and at off study.

Treatment (beta-glucan MM-10-001)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Marianna Koczywas, MD

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: November 21, 2008
• Primary Completion: November 24, 2010
• Study Completion: May 18, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

US (1)