Methods for treating humans having brain cancer
View Patent ↗Among other things, a method of treating a human having brain cancer is, the method comprising administering via a non-continuous dosing regimen to the human having brain cancer, a therapeutically effective amount of a pharmaceutical composition comprising a prodrug or a pharmaceutically acceptable salt thereof, wherein the non-continuous dosing regimen comprises administering the pharmaceutical composition no more frequently than once every seven days for at least two dosings.
1. A method of treating a human having brain cancer, the method comprising administering via a non-continuous dosing regimen to the human having brain cancer, a therapeutically effective amount of a pharmaceutical composition comprising a prodrug of structure (I):
or a pharmaceutically acceptable salt thereof, wherein the non-continuous dosing regimen comprises administering the pharmaceutical composition no more frequently than once every 21 days for at least two dosings in a dosage amount of irinotecan ranging from about 70 mg/m 2 to about 300 mg/m 2 , to thereby maintain sustained therapeutic levels of greater than 0.5 ng/mL of SN-38 in plasma in the human for at least 21 days between dosings.
2. The method of claim 1 , wherein the prodrug comprises a polymer, and the overall nominal average molecular weight of the polymer portion of the prodrug is about 20,000 Da.
3. The method of claim 1 , wherein the administering comprises administering to the subject a dosage amount of irinotecan ranging from about 145 mq/m 2 to 170 mq/m 2 .
4. The method of claim 1 , wherein the administering is effective to prevent tumor growth as measured from the start of treatment.
5. The method of claim 1 , wherein the administering is effective to result in tumor size regression.
6. The method of claim 1 , wherein the administering occurs for 2-6 dosings.
7. A method for achieving extended therapeutic efficacy of irinotecan, the method comprising
administering to a human having brain cancer, a therapeutically effective amount of a pharmaceutical composition comprising a prodrug of structure (I):
or a pharmaceutically acceptable salt thereof, wherein the administering comprises administering the composition at a frequency of between once every 21 days to once every 30 days for at least two dosings in a dosage amount of irinotecan ranging from about 70 mg/m 2 to about 300 mg/m 2 , to thereby achieve for each of the at least two dosings an elimination half-life in plasma of SN-38 that exceeds 750 hours and greater than 0.5 ng/mL of SN-38 in plasma in the human for at least 21 days.
8. The method of claim 7 , wherein the prodrug comprises a polymer, and the overall nominal average molecular weight of the polymer portion of the prodrug is about 20,000 Da.
9. The method of claim 7 , wherein the administering occurs at a frequency of once every 21 days.
10. The method of claim 7 , wherein the administering occurs at a frequency of once every 28 days.
11. The method of claim 7 , wherein the administering occurs for 2-6 dosings.