# US 11,026,914 B2 · Use of dianhydrogalactitol and analogs and derivatives thereof to treat recurrent malignant glioma or progressive secondary brain tumor > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,026,914 B2 - Document ID: US11026914B2 - Status: Granted - Kind: B2 - Application number: 14/682,226 - Filed: 2015-04-09 - Published: 2016-06-09 - Granted: 2021-06-08 - Earliest claimed: 2013-05-31 - Assignees: Del Mar Pharmaceuticals (BC) Ltd. - Applicants: DelMar Pharmaceuticals, Inc. - Inventors: Dennis M. Brown; Kent C. Shih; Anne Steino; Richard Schwartz; Sarath Kanekal; Howard A. Burris, III; Jeffrey A. Bacha; William J. Garner; Shaun Fouse - Web page: https://patentgrep.com/patent/US11026914B2 ## CPC - A61K 31/336: having three-membered rings, e.g. oxirane, fumagillin - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 25/00: Drugs for disorders of the nervous system - A61P 35/00: Antineoplastic agents - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract Methods and compositions suitable for the treatment of malignancies such as recurrent glioma and progressive secondary brain tumor are disclosed. These methods employ a hexitol derivative such as dianhydrogalactitol, a derivative or analog of dianhydrogalactitol, diacetyldianhydrogalactitol, or a derivative or analog of diacetyldianhydrogalactitol. The compositions can include such hexitol derivatives. ## Claims ### Claim 1 A method for the treatment of recurrent glioma or progressive secondary brain tumor comprising the administration of a therapeutically effective quantity of a hexitol derivative selected from the group consisting of dianhydrogalactitol and diacetyldianhydrogalactitol, wherein the recurrent glioma is resistant to temozolomide and bevacizumab, and wherein the hexitol derivative is administered at a therapeutically effective dose of up to 40 mg/m2 for 3 days followed by a nadir/recovery period of 18 to 21 days. ### Claim 2 A method to improve the efficacy and/or reduce the side effects of the administration of a hexitol derivative for treatment of recurrent glioma or progressive secondary brain tumor comprising the steps of: (a) identifying at least one factor or parameter associated with the efficacy and/or occurrence of side effects of the administration of the hexitol derivative for treatment of the malignancy; and (b) modifying the factor or parameter to improve the efficacy and/or reduce the side effects of the administration of the hexitol derivative for treatment of the malignancy, wherein the hexitol derivative is dianhydrogalactitol, and wherein the recurrent glioma is resistant to temozolomide and bevacizumab and the factor or parameter is one or more of dose modification, route of administration, and/or schedule of administration; and wherein the hexitol derivative is administered at a therapeutically effective dose of up to 40 mg/m2 for 3 days followed by a nadir/recovery period of 18 to 21 days. ### Claim 3 (depends on 1) The method of claim 1, wherein the dosing is up to a cumulative effective quantity of 240 mg/m2 in a 33-day treatment cycle. ### Claim 4 (depends on 3) The method of claim 3, wherein the dosing is up to a cumulative effective quantity of 240 mg/m2 in a 33-day treatment cycle. ### Claim 5 (depends on 1) The method of claim 1, wherein the hexitol derivative is administered on days 1, 2 and 3. ### Claim 6 A method for the treatment of recurrent glioma or progressive secondary brain tumor comprising the administration of a therapeutically effective quantity of a hexitol derivative selected from the group consisting of dianhydrogalactitol and diacetyldianhydrogalactitol, wherein the recurrent glioma is resistant to temozolomide and bevacizumab, and wherein the hexitol derivative is administered at a therapeutically effective dose of up to 40 mg/m2 for 3 days followed by a nadir/recovery period of 18 to 21 days, and wherein the dosing is up to a cumulative effective quantity of 240 mg/m2 in a 33-day treatment cycle. ### Claim 7 (depends on 6) The method of claim 6, wherein the hexitol derivative is administered on days 1, 2, and 3. ### Claim 8 A method to improve the efficacy and/or reduce the side effects of the administration of a hexitol derivative for treatment of recurrent glioma or progressive secondary brain tumor comprising the steps of: (a) identifying at least one factor or parameter associated with the efficacy and/or occurrence of side effects of the administration of the hexitol derivative for treatment of the malignancy; and (b) modifying the factor or parameter to improve the efficacy and/or reduce the side effects of the administration of the hexitol derivative for treatment of the malignancy, wherein the hexitol derivative is dianhydrogalactitol, and wherein the recurrent glioma is resistant to temozolomide and bevacizumab and the factor or parameter is one or more of dose modification, route of administration, and/or schedule of administration; and wherein the hexitol derivative is administered at a therapeutically effective dose of up to 40 mg/m2 for 3 days followed by a nadir/recovery period of 18 to 21 days, and wherein the dosing is up to a cumulative effective quantity of 240 mg/m2 in a 33-day treatment cycle.