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Details for Patent: RE38424

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Details for Patent: RE38424

Title: Method for treating taxol side-effects with G-CSF
Abstract:A method of treating a host using taxol comprising administering granulocyte colony-stimulating factor to the host being treated with taxol. The present inventive method allows for increased levels of taxol to be administered to the host in the treatment of various conditions, particularly with respect to ovarian tumors.
Inventor(s): Reed; Eddie (Germantown, MD), Kohn; Elise (Olney, MD), Sarosy; Gisele (Silver Spring, MD)
Assignee: The United States of America as represented by the Department of Health and Human Services (Washington, DC)
Filing Date:Oct 15, 1999
Application Number:09/420,082
Claims:1. A method of treating a host being treated with taxol in an amount sufficient to cause a side effect selected from the group consisting of myelosuppression, mucositis, and peripheral neuropathy, which method comprises administering to said host granulocyte colony-stimulating factor in an amount effective to alleviate or prevent said side effect..]..[.

2. The method of claim 1, wherein said host is being treated with taxol in an amount exceeding about 175 mg/m.sup.2 / 21 days..]..[.

3. A method of claim 1, wherein said side effect is myelosuppression or mucositis..]..[.

4. The method of claim 3, wherein said granulocyte colony-stimulating factor is administered in an amount of at least about 5 .mu.g/kg/day..]..[.

5. The method of claim 4, wherein said granulocyte colony-stimulating factor is administered in an amount of about 10 to about 20 .mu.g/kg/day..]..[.

6. The method of claim 1, wherein said host is being treated with taxol once every three weeks and said granulocyte colony-stimulating factor is administered daily for at least seven days following the taxol treatment..]..[.

7. The method of claim 6 wherein said host is being treated with taxol in an amount of about 200 to about 250 mg/m.sup.2 / 21 days..]..[.

8. The method of claim 1, wherein said host is being treated with taxol to treat a cancerous tumor..]..[.

9. The method of claim 8, wherein said cancerous tumor is a breast, lung or ovarian tumor..]..[.

10. The method of claim 9, wherein said cancerous tumor is an ovarian tumor..]..[.

11. The method of claim 10, wherein said host is being treated with taxol in an amount exceeding about 175 mg/m.sup.2 / 21 days..]..[.

12. The method of claim 11, wherein said granulocyte colony-stimulating factor is administered in an amount of at least about 5 .mu.g/kg/day..]..[.

13. The method of claim 12, wherein said granulocyte colony-stimulating factor is administered in an amount of about 10 to about 20 .mu.g/kg/day..]..[.

14. The method of claim 13, wherein said host is being treated with taxol once every three weeks and said granulocyte colony-stimulating factor is administered daily for at least seven days following the taxol treatment..]..[.

15. The method of claim 14, wherein said host is being treated with taxol in an amount of about 200 to about 250 mg/m.sup.2 / 21 days..]..Iadd.

16. A method of treating a host being treated with taxol in an amount sufficient to cause mucositis, which method comprises administering to said host granulocyte colony-stimulating factor (G-CSF) in an amount effective to alleviate or prevent mucositis..Iaddend..Iadd.

17. The method of claim 16, wherein said host is being treated with taxol in an amount exceeding about 175 mg/m.sup.2 /21 days..Iaddend..Iadd.

18. The method of claim 16, wherein said G-CSF is administered in an amount of at least about 5 .mu.g/kg/day..Iaddend..Iadd.

19. The method of claim 18, wherein said G-CSF is administered in an amount of about 10 to about 20 .mu.g/kg/day..Iaddend..Iadd.

20. The method of claim 16, wherein said host is being treated with taxol once every three weeks and said G-CSF is administered daily for at least seven days following the taxol treatment..Iaddend..Iadd.

21. The method of claim 20, wherein said host is being treated with taxol in an amount of about 200 to about 250 mg/m.sup.2 /21 days..Iaddend..Iadd.

22. The method of claim 16, wherein said host is being treated with taxol to treat a cancerous tumor..Iaddend..Iadd.

23. The method of claim 22, wherein said cancerous tumor is a breast, lung or ovarian tumor..Iaddend..Iadd.

24. The method of claim 23, wherein said host is being treated with taxol in an amount exceeding about 175 mg/m.sup.2 /21 days..Iaddend..Iadd.

25. The method of claim 24, wherein said G-CSF is administered in an amount of at least about 5 .mu.g/kg/day..Iaddend..Iadd.

26. The method of claim 25, wherein said G-CSF is administered in an amount of about 10 to about 20 .mu.g/kg/day..Iaddend..Iadd.

27. The method of claim 26, wherein said host is being treated with taxol once every three weeks and said G-CSF is administered daily for at least seven days following the taxol treatment..Iaddend..Iadd.

28. The method of claim 27, wherein said host is being treated with taxol in an amount of about 200 to about 250 mg/m.sup.2 /21 days..Iaddend..Iadd.

29. A method of treating a host being treated with taxol in an amount sufficient to cause peripheral neuropathy, which method comprises administering to said host granulocyte colony-stimulating factor (G-CSF) in an amount effective to alleviate or prevent peripheral neuropathy..Iaddend..Iadd.

30. The method of claim 29, wherein said host is being treated with taxol in an amount exceeding about 175 mg/m.sup.2 /21 days..Iaddend..Iadd.

31. The method of claim 29, wherein said G-CSF is administered in an amount of at least about 5 .mu.g/kg/day..Iaddend..Iadd.

32. The method of claim 31, wherein said G-CSF is administered in an amount of about 10 to about 20 .mu.g/kg/day..Iaddend..Iadd.

33. The method of claim 29, wherein said host is being treated with taxol once every three weeks and said G-CSF is administered daily for at least seven days following the taxol treatment..Iaddend..Iadd.

34. The method of claim 33, wherein said host is being treated with taxol in an amount of about 200 to about 250 mg/m.sup.2 /21 days..Iaddend..Iadd.

35. The method of claim 29, wherein said host is being treated with taxol to treat a cancerous tumor..Iaddend..Iadd.

36. The method of claim 35, wherein said cancerous tumor is a breast, lung or ovarian tumor..Iaddend..Iadd.

37. The method of claim 36, wherein said host is being treated with taxol in an amount exceeding about 175 mg/m.sup.2 /21 days..Iaddend..Iadd.

38. The method of claim 37, wherein said G-CSF is administered in an amount of at least about 5 .mu.g/kg/day..Iaddend..Iadd.

39. The method of claim 38, wherein said G-CSF is administered in an amount of about 10 to about 20 .mu.g/kg/day..Iaddend..Iadd.

40. The method of claim 39, wherein said host is being treated with taxol once every three weeks and said G-CSF is administered daily for at least seven days following the taxol treatment..Iaddend..Iadd.

41. The method of claim 40, wherein said host is being treated with taxol in an amount of about 200 to about 250 mg/m.sup.2 /21 days..Iaddend..Iadd.

42. A method of treating a host being treated with taxol in an amount sufficient to cause thrombocytopenia, which method comprises administering to said host G-CSF in an amount effective to alleviate or prevent thrombocytopenia..Iaddend..Iadd.

43. The method of claim 42, wherein said host is being treated with taxol in an amount exceeding about 175 mg/m.sup.2 /21 days..Iaddend..Iadd.

44. The method of claim 42, wherein said G-CSF is administered in an amount of at least about 5 .mu.g/kg/day..Iaddend..Iadd.

45. The method of claim 44, wherein said G-CSF is administered in an amount of about 10 to about 20 .mu.g/kg/day..Iaddend..Iadd.

46. The method of claim 42, wherein said host is being treated with taxol once every three weeks and said G-CSF is administered daily for at least seven days following the taxol treatment..Iaddend..Iadd.

47. The method of claim 46, wherein said host is being treated with taxol in an amount of about 200 to about 250 mg/m.sup.2 /21 days..Iaddend..Iadd.

48. The method of claim 42, wherein said host is being treated with taxol to treat a cancerous tumor..Iaddend..Iadd.

49. The method of claim 48, wherein said cancerous tumor is a breast, lung or ovarian tumor..Iaddend..Iadd.

50. The method of claim 49, wherein said host is being treated with taxol in an amount exceeding about 175 mg/m.sup.2 /21 days..Iaddend..Iadd.

51. The method of claim 50, wherein said G-CSF is administered in an amount of at least about 5 .mu.g/kg/day..Iaddend..Iadd.

52. The method of claim 51, wherein said G-CSF is administered in an amount of about 10 to about 20 .mu.g/kg/day..Iaddend..Iadd.

53. The method of claim 52, wherein said host is being treated with taxol once every three weeks and said G-CSF is administered daily for at least seven days following the taxol treatment..Iaddend..Iadd.

54. The method of claim 53, wherein said host is being treated with taxol in an amount of about 200 to about 250 mg/m.sup.2 /21 days..Iaddend..Iadd.

55. A method of treating a host being treated with taxol in an amount sufficient to cause a side effect selected from the group consisting of myelosuppression, mucositis, and peripheral neuropathy, wherein G-CSF is administered to said host in a cycle of therapy with taxol and said host develops a side effect, which method comprises administering G-CSF to said host in a subsequent cycle of taxol therapy in an amount effective to alleviate or prevent said side effect..Iaddend..Iadd.

56. The method of claim 55, wherein taxol is administered at a dosage level of about 250 mg/m.sup.2 /day..Iaddend..Iadd.

57. The method of claim 56, wherein, in said cycle of therapy with taxol, about 10 .mu.g/kg/day of G-CSF is administered..Iaddend..Iadd.

58. The method of claim 57, wherein, in said subsequent cycle of therapy with taxol, about 10-20 .mu.g/kg/day of G-CSF is administered..Iaddend..Iadd.

59. The method of claim 58, wherein, in said subsequent cycle of therapy with taxol, about 15-20 .mu.g/kg/day of G-CSF is administered..Iaddend..Iadd.

60. The method of claim 58, wherein said method comprises another subsequent cycle of taxol therapy and in said another subsequent cycle of taxol therapy, said host develops a side effect and the amount of taxol used to treat said host is reduced..Iaddend..Iadd.

61. The method of claim 60, wherein the amount of taxol is about 200 mg/m.sup.2 /kg..Iaddend..Iadd.

62. The method of claim 59, wherein said method comprises another subsequent cycle of taxol therapy and in said another subsequent cycle of taxol therapy, said host develops a side effect and the amount of taxol used to treat said host is reduced..Iaddend..Iadd.

63. The method of claim 62, wherein the amount of taxol is about 200 mg/m.sup.2 /kg..Iaddend..Iadd.

64. The method of claim 55, wherein said myelosuppression is neutropenia..Iaddend..Iadd.

65. The method of claim 64, wherein said neutropenia is febrile..Iaddend.
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