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Claims for Patent: 6,723,351

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Claims for Patent: 6,723,351

Title: Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol
Abstract:The invention relates to the use of arsenic compounds to treat a variety of leukemia, lymphoma and solid tumors. Further, the arsenic compounds may be used in combination with other therapeutic agents, such as a retinoid. The invention also provides a process for producing arsenic trioxide formulations.
Inventor(s): Warrell, Jr.; Raymond P. (Westfield, NJ), Pandolfi; Pier Paolo (New York, NY), Gabrilove; Janice L. (New York, NY)
Assignee: Memorial Sloan-Kettering Cancer Center (New York, NY)
Application Number:10/425,785
Patent Claims: 1. A method for treating acute promyelogenous leukemia in a human comprising administering 0.15 mg/kg arsenic trioxide once per day.

2. The method of claim 1, wherein said arsenic trioxide is administered until bone marrow remission, which constitutes a first administration.

3. The method of claim 2, further comprising a second administration of 0.15 mg/kg arsenic trioxide once per day for 25 doses.

4. The method of claim 3, wherein said second administration is administered 3 to 6 weeks after the first administration.

5. The method of claim 3, wherein said second administration is administered for up to five weeks.

6. The method of claim 5, wherein said second administration is administered at five doses per week.

7. The method of claim 3, further comprising repeating said second administration.

8. The method of claim 7, wherein said second administration is repeated every 3 to 6 weeks.

9. The method of claim 8, wherein said second administration is repeated until a total of between two and ten cycles of said second administration are completed.

10. The method of claim 9, further comprising repeating said second administration until a total of two cycles of said second administration are completed.

11. The method of claim 9, further comprising repeating said second administration until a total of ten cycles of said second administration are completed.

12. The method of claim 1, wherein said arsenic trioxide is administered for up to sixty days, which constitutes a first administration.

13. The method of claim 12, further comprising a second administration of 0.15 mg/kg arsenic trioxide once per day for 25 doses.

14. The method of claim 13, wherein said second administration is administered 3 to 6 weeks after the first administration.

15. The method of claim 13, wherein said second administration is administered for up to five weeks.

16. The method of claim 15, wherein said second administration is administered at five doses per week.

17. The method of claim 13, further comprising repeating said second administration.

18. The method of claim 17, wherein said second administration is repeated every 3 to 6 weeks.

19. The method of claim 18, wherein said second administration is repeated until a total of between two end ten cycles of said second administration are completed.

20. The method of claim 19, further comprising repeating said second administration until a total of two cycles of said second administration are completed.

21. The method of claim 19, further comprising repeating said second administration until a total of ten cycles of said second administration are completed.

22. A method for treating acute myelogenous leukemia in a human, comprising: determining a therapeutically effective dosage of arsenic trioxide based on i) the weight of a subject diagnosed with acute myelogenous leukemia and (ii a dosage amount of 0.15 mg/kg; and administering the therapeutically effective dosage of arsenic trioxide once per day.

23. The method of claim 22, wherein said acute myologenous leukemia is acute promyelogenous leukemia.

24. The method of claim 23, wherein said arsenic trioxide is administered until bone marrow remission, which constitutes a first administration.

25. The method of claim 24, further comprising a second administration of 0.15 mg/kg arsenic trioxide once per for 25 doses.

26. The method claim 25, wherein said second administration is administered 3 to 6 weeks after the first administration.

27. The method of claim 25, wherein said second administration is administered for up to five weeks.

28. The method of claim 27, wherein said second administration is administered at five doses per week.

29. The method of claim 25, further comprising repeating said second administration.

30. The method of claim 29, wherein said second administration is repeated every 3 to 6 weeks.

31. The method of claim 30, wherein said second administration is repeated until a total of between two and ten cycles of said second administration are completed.

32. The method of claim 31, further comprising repeating said second administration until a total of two cycles of said second administration are completed.

33. The method of claim 31, further comprising repeating said second administration until a total of ten cycles of said second administration are completed.

34. The method of claim 23, wherein said arsenic trioxide is administered for up to sixty days, which constitutes a first administration.

35. The method of claim 34, further comprising a second administration of 0.15 mg/kg arsenic trioxide once per day for 25 doses.

36. The method of claim 35, wherein said second administration is administered 3 to 6 weeks after the first administration.

37. The method of claim 35, wherein said second administration is administered for up to five weeks.

38. The method of claim 37, wherein said second administration is administered at five doses per week.

39. The method of claim 35, further comprising repeating said second administration.

40. The method of claim 39, wherein said second administration is repeated every 3 to 6 weeks.

41. The method of claim 40, wherein said second administration is repeated until a total of between two and ten cycles of said second administration are completed.

42. The method of claim 41, further comprising repeating said second administration until a total of two cycles of said second administration are completed.

43. The method of claim 41, further comprising repeating said second administration until a total of ten cycles of said second administration are completed.

44. A method for treating acute promyelogenous leukemia, comprising determining a dosage amount of arsenic trioxide for the treatment of a patient diagnosed with acute promyelogenous leukemia, based on the weight of the patient and a dose of 0.15 mg/kg of patient body weight, and administering arsenic trioxide in said dosage amount to said patient.

45. The method of claim 44, wherein said arsenic trioxide is administered until bone marrow remission, which constitutes a first administration.

46. The method of claim 45, further comprising a second administration of 0.15 mg/kg arsenic trioxide for 25 doses.

47. The method of claim 46, wherein said second administration is administered 3 to 6 weeks after the first administration.

48. The method of claim 46, wherein said second administration is administered for up to five weeks.

49. The method of claim 48, wherein said second administration is administered at five doses per week.

50. The method of claim 46, further comprising repeating said second administration.

51. The method of claim 50, wherein said second administration is repeated every 3 to 6 weeks.

52. The method of claim 51, wherein said second administration is repeated until a total of between two and ten cycles of said second administration are completed.

53. The method of claim 52, further comprising repeating said second administration until a total of two cycles of said second administration are completed.

54. The method of claim 52, further comprising repeating said second administration until a total of ten cycles of said second administration are completed.

55. The method of claim 44, wherein said arsenic trioxide is administered for up to sixty days, which constitutes a first administration.

56. The method of claim 55, further comprising a second administration of 0.15 mg/kg arsenic trioxide for 25 doses.

57. The method of claim 56, wherein said second administration is administered 3 to 6 weeks after the first administration.

58. The method of claim 56, wherein said second administration is administered for up to five weeks.

59. The method of claim 58, wherein said second administration is administered at five doses per week.

60. The method of claim 56, further comprising repeating said second administration.

61. The method of claim 60, wherein said second administration is repeated every 3 to 6 weeks.

62. The method of claim 61, wherein said second administration is repeated until a total of between two and ten cycles of said second administration are completed.

63. The method of claim 62, further comprising repeating said second administration until a total of two cycles of said second administration are completed.

64. The method of claim 62, further comprising repeating said second administration until a total of ten cycles of said second administration are completed.
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