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  Treatment method against side-effects of chemotherapyUSPTO Application #: 20050215514Title: Treatment method against side-effects of chemotherapy Abstract: A method and composition is provided for organ rescue wherein a specific counter-measure is applied locally to a tissue at risk for or exhibiting an adverse side effect of a cancer treatment. More particularly, the method and composition is directed at controlling Hand-Foot Syndrome, a painful redness and cracking of the skin of the hands and feet which can occur with systemic treatment with 5-fluorouracil or a precursor thereof. Uracil ointment is applied to the skin of the hands and feet to prevent Hand-Foot Syndrome which can occur from systemic administration of 5-fluorouracil (or precursor thereof) as cancer treatment. (end of abstract)
Agent: Dechert LLP - Palo Alto, CA, US Inventor: John P. Ford USPTO Applicaton #: 20050215514 - Class: 514049000 (USPTO) Related Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), O-glycoside, , Nitrogen Containing Hetero Ring, Pyrimidines (including Hydrogenated) (e.g., Cytosine, Etc.) The Patent Description & Claims data below is from USPTO Patent Application 20050215514. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS-REFERENCES [0001] This application is a continuation-in-part application of Ser. No. 10/364,383 filed Feb. 12, 2003, and which claims benefit from Provisional Application Ser. No. 60/355,764, filed Feb. 12, 2002. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The invention concerns reducing side-effects of certain chemotherapy, and particularly, side-effects manifested topically in areas of the hands and feet. [0004] 2. The Related Art [0005] Chemotherapy can result in predictable toxicity to organs. An important chemotherapy is the use of 5-fluorouracil (5FU), and its precursors, such as capecitabine available as Xeloda.RTM., a drug produced by Roche Pharmaceuticals. Xeloda.RTM. and 5FU can induce a skin side effect called "Hand-Foot Syndrome" (HFS). This syndrome can cause pain, a loss of feeling (numbness), a tingling feeling, swelling and redness in the palms of your hands and/or soles of feet. Some patients also get a rash, discolored skin, nail problems, and hair loss. Severe cases of HFS can be very painful, cause skin of the hands and feet to blister and peel. [0006] Compilations relevant to this field include the following. [0007] Mackean M, Planting A, Twelves C et al: Phase 1 and pharmacologic study of intermittent twice-daily oral therapy with capecitabine in patients with advanced and/or metastatic cancer. J. Clin Oncol 16:2977-2985, 1998. [0008] Cao S, Frank C, Shirasaka et al: 5-fluorouracil pro drug: role of anabolic and catabolic pathway modulation in therapy of colorectal cancer. Clin Can Res 1:839-845, 1995. [0009] Hoff, P: The tegafur-based dehydropyrimidine dehydrogenase inhibitory fluoropyrimidines, UFT/Leucoverin (Orzel) and S-1: a review of their clinical development and therapeutic potential. Invest New Drugs 18:331-342, 2000. [0010] Johnson M, Hageboutros A, Wang K, et al: Life threatening toxicity in a dihydropyrimidine dehydrogenase-deficient patient after treatment with topical 5-fluorouracil. Clin Can Res 5:2006-2011, 1999. SUMMARY OF THE INVENTION [0011] The present invention introduces the concept of "organ rescue." By applying locally a uracil ointment, certain adverse side effects of 5FU and its precursors can be averted. Uracil and 5FU are anabolized by the same enzymes. Uracil and 5FU differ chemically only in the H (Uracil) or F(5FU) at 5 position. Uracil is in high concentration when the uracil ointment is applied at the skin subject to HFS ("rescuing" the skin). After topical application of the uracil ointment to the hands and feet, uracil has negligible concentration in the body generally and specifically in the tumor containing regions of the body. The application of 1% uracil ointment prevents the anabolism of 5FU into a toxic form in those tissues, subjacent to the ointment application, where uracil concentration is high. Adverse side effects of 5FU are countered while preserving the anti-cancer systemic efficacy of the 5FU. With application of the uracil ointment to the hands and feet, the systemic uracil concentration is low. No longer is it necessary to reduce the systemic dose of 5FU/precursor in efforts to avoid the HFS side-effect. [0012] The concept of "organ rescue" can be applied to other organs and to other chemotherapy agents which have specific organ toxicities. In each case, the rescue agent is directly applied in high local concentration to a tissue subject to toxicity thereby reversing the unwanted side effect of systematically administered anti-cancer agent. The rescue agent must, in each case, specifically reverse the local efficacy of the cancer treatment. The rescue agent must have negligible systemic concentration in the body to preserve the anti-cancer efficacy of the cancer treatment. [0013] Previous work presumed the oral administration of uracil, systemically together with a precursor of 5FU would increase the metabolism of the 5FU and decrease its degradation. The resultant effect was presumed to be an increase in toxicity. This oral agent (UFT) is administered systematically at a dose of 1000-2000 mg uracil (4.times. molar excess over 5FU) per day. It is possible that the high uracil dose in UFT can counteract the anti-cancer effect of the 5FU. The 1% uracil ointment is administered at 1-2 cc or 10-20 mg uracil per day. [0014] This logic for creating mixtures of uracil and 5FU/precursor was that the uracil compared to 5FU would be preferentially degraded and metabolized. Thus, the application of a 1% uracil ointment might be expected to increase HFS. Yet, quite the opposite was observed. The 1% uracil ointment eliminated the HFS toxicity of cancer treatment by 5FU or its precursor. DETAILED DESCRIPTION OF THE INVENTION [0015] Use of uracil formulations can be effective as post-chemotherapy treatment providing benefit to the adverse skin effects of the chemotherapy chemicals. Among those effects that can be mitigated include redness (erythema) and cracking. [0016] Chemotherapy agents applicable to the present treatment and method include 5-fluorouracil or precursors thereof [0017] Amounts of uracil as the rescue active in rescue formulations may range from about 0.01 to about 60%, preferably from about 0.5 to about 5%, optimally from about 1% by weight. [0018] Formulations of uracil may be in any convenient format. These include creams, lotions, aerosol sprays, roll-on liquids, sticks and pad forms. [0019] Treatment compositions of the present invention may be anhydrous or emulsions. Oil and water emulsions are preferred for the present invention. Whether anhydrous or emulsion type, compositions of the present invention may further include a variety of pharmaceutically acceptable carriers and skin actives. Amounts of the carrier may range from about 1 to about 99%, preferably from about 5 to about 70%, optimally from about 10 to about 40% by weight. Among the carriers are emollients, water, inorganic powders, foaming agents, emulsifiers, fatty alcohols, fatty acids, and combinations thereof [0020] Emollients are substances selected from polyols, esters and hydrocarbons. Polyols suitable for the invention may include propylene glycol, dipropylene glycol, polypropylene glycol, polyethylene glycol, sorbitol, hydroxypropyl sorbitol, hexylene glycol, 1,3-butylene glycol, 1,2,6-hexanetriol, glycerin, ethoxylated glycerin, propoxylated glycerin, xylitol and mixtures thereof. Continue reading... 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