Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments beta-glucan mm-10-001, flow cytometry, laboratory biomarker analysis, questionnaire administration
Phase phase 1
Sponsor City of Hope Medical Center
Collaborator National Cancer Institute (NCI)
Start date November 2008
End date August 2016
Trial size 20 participants
Trial identifier NCT00857025, 07243, CDR0000634737, CHNMC-07243, P30CA033572

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
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
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.
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.
questionnaire administration
Assessment pre-study and week 5, week 9, week 13 and at off study.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase I Study of MM-10-001 In Advanced Non Small Lung Cancer
Principal investigator Marianna Koczywas, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by City of Hope Medical Center.