Maitake is reported with immunomodulatory functions against tumor growth in terms of its unique molecular structure, β-glucan polysaccharides within 1, 6 main chain having 1, 3 branches and a 1, 3 main chain having 1, 6 branches configuration. The β-glucan is identified as a main component of BLEX 404. Not only with therapeutic potential on several types of cancer, BLEX 404 has also shown the potential to improve hematopoiesis, granulocyte colony stimulating factor (G-CSF) production, and the cytotoxicity activity of immune cells in recent animal studies. Its antitumor effect on tumor-bearing mice is exerted by enhancing the immune system through activation of macrophages, T cells, and natural killer (NK) cells. The activation of antigen presenting cells (APCs) such as macrophages, dendritic cells (DCs) via BLEX 404 administration is in response to secretion of interleukin-12 (IL-12). BLEX 404 has been found to enhance the activity of immunocompetent cells such as helper T cells, cytotoxic T cells, and NK cells either by i.p injection or oral intake, therefore, it stimulates innate and adaptive immunity. BLEX 404 enhances hematopoiesis by increasing mouse bone marrow cell and human cord blood cell differentiation into granulocytes-macrophages (GMs), granulopoiesis and mobilization of granulocytes, and granulocyte macrophage colony-stimulating factor (GM-CSF) or G-CSF production. One related phase I healthy human trial by treating with Maitake D-fraction was examined in Italy. The published data of trial for solid tumor patients was in the year 2003 in Japan, and another for breast cancer patients was in the year 2009 in the United States executed by Memorial Sloan Kettering Cancer Center (MSKCC). Lately, same team amended IND for myelodysplastic syndromes (MDS) human trial. All those human experiences are the fundamental of developing BLEX 404 Oral Liquid.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
BLEX 404 Oral Liquid, PO, BID
Taipei Veteran General Hospital
Taipei, Taiwan
DLT determination
To determine the dose-limiting toxicity (DLT) in the first cycle of combination use
Time frame: end of 21 days
RDL Determination
To determine the recommended dose level (RDL) in the first cycle of combination use
Time frame: end of 21 days
Overall response rate (PR + CR) after 4 cycles of combination use
Overall response rate (PR + CR) after 4 cycles of combination use in BLEX 404 \+ Pemetrexed \& Cisplatin Therapy.
Time frame: end of 84 days
Overall response rate (PR + CR) after at least 1 cycle of combination use
Overall response rate (PR + CR) after at least 1 cycle of combination use in BLEX 404 \+ Pemetrexed \& Cisplatin Therapy.
Time frame: end of 126 days
Rate of grade 3/4 hematological toxicity
AEs that occur during the study will be rated by using the grades defined in Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. There are 5 grades, includes Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life threatening) and Grade 5 (Death).
Time frame: end of 126 days
Effect on Quality of Life by EORTC QLQ-C30
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. A negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement.
Time frame: end of 126 days
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