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Abstract
The present invention is directed to compositions and methods for the treatment of cancers, particularly cancers of epithelial origin. Therapy with a plurality of nutraceutical, non-chemotherapeutic and chemotherapeutic agents, that together target a plurality of cancer-supportive processes in a patient are disclosed. Among other things, the present invention encompasses the insight that redundant targeting of multiple such pathways provides effective treatment of various cancer, including late-stage cancers, metastasized cancers, and/or cancers that have failed treatment with traditional chemotherapy and/or other therapeutic modalities.
Core Innovation
The invention relates to a method of treating cancer in which a subject having cancer receives a combination therapy. The cancer comprises solid tumors and is Stage II, Stage III, or Stage IV, and the combination therapy comprises metronomic cyclophosphamide, metformin, alpha-lipoic acid, curcumin, genistein, melatonin, and naltrexone.
The disclosed approach is described as an integrative cancer therapy targeting multiple hallmark cancer-supportive processes, with emphasis on angiogenesis and vasculogenic mimicry, dysregulated apoptosis, Warburg metabolism, invasion and metastasis signaling, and immune surveillance. It includes individualized selection based on blood/tissue analyses and uses combinations of nutraceuticals or natural compounds together with non-chemotherapeutic and chemotherapeutic agents.
The disclosure provides representative component groupings and tables listing compound sets, including metronomic cyclophosphamide and compounds such as metformin, alpha-lipoic acid, curcumin, genistein, melatonin, and naltrexone, with optional inclusion of other named agents. It also provides a mechanistic rationale for addressing dysregulated pathways including PI3K/AKT/mTOR, MAPK/ERK, EGFR, HIF-1α/VEGF, NF-κB, and p53/p21, and for addressing the Warburg effect, glucose oxidation, oxidative stress or COX-2, and apoptosis.
The disclosed therapy is described as applicable to late-stage, metastasized, or relapsed cancers, and to epithelial-origin cancers and solid tumors. It is described as adjunctive to chemotherapy in certain embodiments, and the disclosure presents clinical-style exemplification with patient protocols and reported outcomes or side effects. It also states that the therapy is tailored and can involve metronomic dosing and adjunct use across treatment settings.
Claims Coverage
The independent claim defines a cancer-treatment method for solid tumors at Stages II–IV with an integrative combination therapy. One independent claim is identified in the provided content, and the coverage below focuses on the inventive features recited in that claim and the explicitly tied refinements.
Stage II–IV solid tumor combination therapy with fixed seven-component regimen
Administering a combination therapy to a subject having solid tumors that are Stage II, Stage III, or Stage IV, wherein the combination therapy comprises metronomic cyclophosphamide, metformin, alpha-lipoic acid, curcumin, genistein, melatonin, and naltrexone.
Adjunctive use with chemotherapy
Defining the method such that the combination therapy is administered as an adjunct to chemotherapy.
Treatment of Stage III or Stage IV
Performing the method for a subject with Stage III or Stage IV cancer.
The claim coverage centers on a method of treating solid tumors at Stages II–IV using metronomic cyclophosphamide, metformin, alpha-lipoic acid, curcumin, genistein, melatonin, and naltrexone, with refinements for adjunct chemotherapy use and for restricting the cancer stage to Stage III or Stage IV.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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