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Claims for Patent: 6,727,253

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Claims for Patent: 6,727,253

Title: Treatment of accidental extravasation of anthracyclines
Abstract:The present invention relates to a method for pharmacological treatment of accidental extravasation of topoisomerase II poisons, such as anthracyclines. In particular, the invention relates to the use of a topo II catalytic inhibitor, such as the bisdioxopiperazine ICRF-187, for the treatment of an accidental extravasation of a topoisomerase II poison. A method for treatment of such extravasation of a topoisomerase poison such as the anthracyclines, daunorubicin, doxorubicin, epirubicin, or idarubicin is disclosed.
Inventor(s): Langer; Seppo W. (Gentofte, DK), Jensen; Peter B. (Farum, DK), Sehested; Maxwell (Copenhagen, DK)
Assignee: Antianthra APS (Farum, DK)
Application Number:09/893,521
Patent Claims: 1. A method for preventing or treating local tissue damage due to accidental extravasation of a cytotoxic topoisomerase II poison in a patient receiving treatment with the topoisomerase II poison, comprising administration of a topo II catalytic inhibitor to the patient in need thereof, where said topo II catalytic inhibitor is a bisdioxopiperazine.

2. A method according to claim 1 wherein the bisdioxopiperazine ICRF-187, (dexrazoxane).

3. A method according to claim 1 wherein the administration of the topo II catalytic inhibitor is by local administration to the tissue affected by the extravasation of the topoisomerase II poison.

4. A method according to claim 1 wherein the administration of the topo II catalytic inhibitor is by systemic administration to the tissue affected by the extravasation of the topoisomerase II poison.

5. A method according to claim 1 wherein the topoisomerase II poison is selected from the group consisting of etoposide, etoposide phosphate, teniposide, mitoxantrone, and m-AMSA.

6. A method according to claim 1 wherein the topo II catalytic inhibitor is administered after the treatment with the topoisomerase II poison.

7. A method according to claim 1 wherein the topo II catalytic inhibitor is administered after treatment with the topoisomerase II poison and while the tissue contains topoisomerase II poison or its active metabolites.

8. A method according to claim 3 wherein the topo II inhibitor is administered after the occurrence of accidental extravasation of said topoisomerase II poison.

9. A method according to claim 8 wherein the topo II inhibitor is administered after first occurrence of pain, erythema or swelling due to accidental extravasation of said topoisomerase II poison.

10. A method according to claim 7 wherein the topo II inhibitor is administered more than 24 hours after administration of the topoisomerase II poison.

11. A method according to claim 7 wherein the topo II inhibitor is first administered more than 24 hours after administration of the topoisomerase II poison.

12. A method according to claim 1 wherein the topo II catalytic inhibitor is administered substantially concomitantly with the administration of the topoisomerase II poison.

13. A method according to claim 1, wherein the topo II catalytic inhibitor is administered in the period within 3 weeks after the administration of the topo II poison.

14. A method according to claim 1, wherein the topo II catalytic inhibitor is administered in the period within 18 hours after the administration of the topo II poison.

15. A method according to claim 1, wherein the topo II catalytic inhibitor is administered with at least 2 repeated dosages.

16. A method according to claim 15, wherein the repeated dosages are administered with an interval of 1 to 3 days from the first dosage.

17. A method according to claim 15, wherein the repeated dosages are administered with an interval of at the most 24 hours from the first dosage of the topo II catalytic inhibitor.

18. A method according to claim 1, wherein the II catalytic inhibitor is administered with at least 3 repeated dosages.

19. A mehtod according to claim 18, wherein the topo II catalytic inhibitor is administered with at least 4 repeated dosages.

20. A method according to claim 1, wherein the topo II catalytic inhibitor is administered within 12 hours of recognition or suspicion of extravasation of the topoisomerase II poison.

21. A method according to claim 1, wherein the topo II catalytic inhibitor is administered within 12 hours of administration of the topoisomerase II poison.

22. A method according to claim 1, wherein the topoisomerase II poison is an anthracycline.

23. A method according to claim 22 wherein the topoisomerase II poison is selected from the group consisting of daunorubicin, doxorubicin, idarubicin, and epirubicin.

24. A method according to claim 1, wherein the topoisomerase II poison is daunorubicin.

25. A method according to claim 1, wherein the topoisomerase II poison is doxorubicin.

26. A method according to claim 1, wherein the topoisomerase II poison is idarubicin.

27. A method according to claim 1, wherein the topoisomerase II poison is epirubicin.

28. A method according to claim 1 wherein the topo II inhibitor is administered in an amount sufficient to be present in the tissue to be prevented from or treated for tissue damage.

29. A method according to claim 1, wherein the topo II catalytic inhibitor is administered within 6 hours of administration of the topoisomerase II poison.

30. A method according to claim 1, wherein the topo II catalytic inhibitor is administered within 4 hours of administration of the topoisomerase II poison.

31. A method according to claim 1, wherein the topo II catalytic inhibitor is administered within 2 hours of administration of the topoisomerase II poison.
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