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Details for Patent: 7,148,257

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Details for Patent: 7,148,257

Title:Methods of treating mesothelioma with suberoylanilide hydroxamic acid
Abstract: Methods for treating mesothelioma comprising administering the histone deacetylase inhibitor suberoylanilide hydroxamic acid (SAHA) are disclosed.
Inventor(s): Bacopoulos; Nicholas G. (New York, NY), Chiao; Judy H. (Berkeley Heights, NJ), Miller; Thomas A. (New York, NY), Paradise; Carolyn M. (Cortland Manor, NY), Richon; Victoria M. (Rye, NY)
Assignee: Merck HDAC Research, LLC (Boston, MA) Sloan-Kettering Institute for Cancer Research (New York, NY)
Filing Date:Aug 26, 2003
Application Number:10/650,025
Claims:1. A method of treating mesothelioma in a subject, said method comprising the step of administering to the subject an effective amount of a pharmaceutical composition comprising suberoylanilide hydroxamic acid (SAHA), represented by the structure: ##STR00063## or a pharmaceutically acceptable salt or hydrate thereof, and a pharmaceutically acceptable carrier or diluent, in an amount effective to treat mesothelioma in said subject.

2. The method of claim 1, wherein the pharmaceutical composition is administered orally.

3. The method of claim 2, wherein said composition is contained within a gelatin capsule.

4. The method of claim 3, wherein said carrier or diluent is microcrystalline cellulose.

5. The method of claim 4, further comprising sodium croscarmellose as a disintegrating agent.

6. The method of claim 5, further comprising magnesium stearate as a lubricant.

7. The method of claim 2, wherein said composition is administered to the subject at a total daily dosage of between about 25 4000 mg/m.sup.2.

8. The method of claim 2, wherein said composition is administered once-daily, twice-daily or three times-daily.

9. The method of claim 8, wherein said composition is administered once daily at a dose of about 200 600 mg.

10. The method of claim 8, wherein said composition is administered twice daily at a dose of about 200 400 mg.

11. The method of claim 8, wherein said composition is administered twice daily at a dose of about 200 400 mg intermittently.

12. The method of claim 11, wherein said composition is administered three to five days per week.

13. The method of claim 11, wherein said composition is administered three days a week.

14. The method of claim 13, wherein said composition is administered at a dose of about 200 mg.

15. The method of claim 13, wherein said composition is administered at a dose of about 300 mg.

16. The method of claim 13, wherein said composition is administered at a dose of about 400 mg.

17. The method of claim 2, wherein said composition is administered three times-daily.

18. A method of treating mesothelioma in a subject, said method comprising the step of administering orally to the subject an effective amount of a pharmaceutical composition comprising suberoylanilide hydroxamic acid (SAHA) or a pharmaceutically acceptable salt or hydrate thereof, represented by the structure: ##STR00064## and a pharmaceutically acceptable carrier or diluent, wherein the amount of SAHA is effective to treat mesothelioma in said subject.

19. The method of claim 18, wherein said composition is contained within a gelatin capsule.

20. The method of claim 19, wherein said carrier or diluent is microcrystalline cellulose.

21. The method of claim 20, further comprising sodium croscarmellose as a disintegrating agent.

22. The method of claim 21, further comprising magnesium stearate as a lubricant.

23. The method of claim 18, wherein said composition is administered to the subject at a total daily dosage of between about 25 4000 mg/m.sup.2.

24. The method of claim 18, wherein said composition is administered once-daily, twice-daily or three times-daily.

25. The method of claim 24, wherein said composition is administered once daily at a dose of about 200 600 mg.

26. The method of claim 24, wherein said composition is administered twice daily at a dose of about 200 400 mg.

27. The method of claim 26, wherein said composition is administered at a dose of about 200 mg.

28. The method of claim 26, wherein said composition is administered at a dose of about 300 mg.

29. The method of claim 26, wherein said composition is administered at a dose of about 400 mg.

30. The method of claim 24, wherein said composition is administered twice daily at a dose of about 200 400 mg intermittently.

31. The method of claim 30, wherein said composition is administered three to five days per week.

32. The method of claim 30, wherein said composition is administered three days a week.

33. The method of claim 32, wherein said composition is administered at a dose of about 200 mg.

34. The method of claim 32, wherein said composition is administered at a dose of about 300 mg.

35. The method of claim 32, wherein said composition is administered at a dose of about 400 mg.

36. The method of claim 30, wherein said composition is administered at a dose of about 200 mg.

37. The method of claim 30, wherein said composition is administered at a dose of about 300 mg.

38. The method of claim 30, wherein said composition is administered at a dose of about 400 mg.

39. The method of claim 18, wherein said composition is administered three times-daily.

40. A method of treating mesothelioma in a subject, said method comprises the step of administering to the subject a total daily dose of up to about 800 mg of a pharmaceutical composition comprising suberoylanilide hydroxamic acid (SAHA) or a pharmaceutically acceptable salt or hydrate thereof, represented by the structure: ##STR00065## and a pharmaceutically acceptable carrier or diluent, wherein the mesothelioma in said subject is treated.

41. The method of claim 40, wherein the pharmaceutical composition is administered orally.

42. The method of claim 41, wherein said composition is contained within a gelatin capsule.

43. The method of claim 42, wherein said carrier or diluent is microcrystalline cellulose.

44. The method of claim 43, further comprising sodium croscarmellose as a disintegrating agent.

45. The method of claim 44, further comprising magnesium stearate as a lubricant.

46. The method of claim 41, wherein said composition is administered once-daily, twice-daily or three times-daily.

47. The method of claim 46, wherein said composition is administered once daily at a dose of about 200 600 mg.

48. The method of claim 46, wherein said composition is administered twice daily at a dose of about 200 400 mg.

49. The method of claim 46, wherein said composition is administered twice daily at a dose of about 200 400 mg intermittently.

50. The method of claim 49, wherein said composition is administered three to five days per week.

51. The method of claim 49, wherein said composition is administered three days a week.

52. The method of claim 51, wherein said composition is administered at a dose of about 200 mg.

53. The method of claim 51, wherein said composition is administered at a dose of about 300 mg.

54. The method of claim 51, wherein said composition is administered at a dose of about 400 mg.

55. The method of claim 41, wherein said composition is administered three times-daily.
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