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Claims for Patent: 8,299,078

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Claims for Patent: 8,299,078

Title:Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Abstract: T cell lymphoma is treated by administering to a patient suffering from T cell lymphoma a therapeutically effective amount of 10-propargyl-10-deazaaminopterin. Remission is observed in human patients, even with drug resistant T cell lymphoma at weekly dosages levels as low as 30 mg/m.sup.2. In general, the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.
Inventor(s): O'Connor; Owen A. (Scarsdale, NY), Sirotnak; Francis M. (Hampton Bays, NY)
Assignee: Sloan-Kettering Institute for Cancer Research (New York, NY)
Application Number:12/603,117
Patent Claims: 1. A method for treatment of T cell lymphoma comprising administering to a human having a T cell lymphoma a composition comprising a therapeutically effective amount of 10-propargyl-10-deazaaminopterin.

2. A method for treatment of T cell lymphoma comprising administering to a human having a T cell lymphoma a composition comprising a therapeutically effective amount of 10-propargyl-10-deazaaminopterin, wherein the composition is formulated with 10-propargyl-10-deazaaminopterin substantially free of 10-deazaaminopterin.

3. The method of claim 1, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

4. The method of claim 1, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

5. The method of claim 4, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

6. The method of claim 3, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

7. The method of claim 1, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

8. The method of claim 7, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 135 to 275 mg/m.sup.2 per dose.

9. The method of claim 1, wherein the T cell lymphoma is peripheral T cell lymphoma.

10. The method of claim 1, wherein the T cell lymphoma is cutaneous T cell lymphoma.

11. The method of claim 10, wherein the cutaneous T cell lymphoma is Mycosis fungoides/Sezary syndrome.

12. The method of claim 1, wherein the T cell lymphoma is selected from: lymphoblastic lymphomas in which the malignancy occurs in primitive lymphoid progenitors from the thymus; mature or peripheral T cell neoplasms selected from the group consisting of T cell prolymphocytic leukemia; T-cell granular lymphocytic leukemia; aggressive NK-cell leukemia; cutaneous T cell lymphoma; anaplastic large cell lymphoma, T cell type; enteropathy-type T cell lymphoma; Adult T-cell leukemia/lymphoma including those associated with Human T-lymphotropic virus-1 (HTLV-1); angioimmunoblastic T cell lymphoma; and subcutaneous parmiculitic T cell lymphoma; and peripheral T cell lymphomas that initially involve a lymph node paracortex and never grow into a true follicular pattern.

13. The method of claim 1, wherein the T cell lymphoma is relapsed or refractory T cell lymphoma.

14. The method of claim 1, wherein the T cell lymphoma is lymphoblastic lymphoma in which the malignancy occurs in primitive lymphoid progenitors from the thymus.

15. The method of claim 1, wherein the T cell lymphoma is T cell prolymphocytic leukemia.

16. The method of claim 1, wherein the T cell lymphoma is T-cell granular lymphocytic leukemia.

17. The method of claim 1, wherein the T cell lymphoma is aggressive NK-cell leukemia.

18. The method of claim 1, wherein the T cell lymphoma is anaplastic large cell lymphoma, T cell type.

19. The method of claim 1, wherein the T cell lymphoma is enteropathy-type T cell lymphoma.

20. The method of claim 1, wherein the T cell lymphoma is Adult T-cell leukemia/lymphoma including those associated with HTLV-1.

21. The method of claim 1, wherein the T cell lymphoma is angioimmunoblastic T cell lymphoma.

22. The method of claim 1, wherein T cell lymphoma is subcutaneous panniculitic T cell lymphoma.

23. The method of claim 1, wherein the T cell lymphoma is peripheral T cell lymphoma that initially involves a lymph node paracortex and never grows into a true follicular pattern.

24. The method of claim 1, wherein the 10-propargyl-10-deazaaminopterin is administered in one or more cycles, each cycle comprising administration once weekly for six weeks in an amount of from 30 to 150 mg/m.sup.2 per dose followed by a one week rest.

25. The method of claim 1, wherein the 10-propargyl-10-deazaaminopterin is administered in one or more seven-week cycles, each cycle comprising administration once weekly for six weeks in an amount of from 30 to 150 mg/m.sup.2 per dose followed by a one week rest.

26. The method of claim 1, further comprising supplementation with folic acid and vitamin B.sub.12.

27. The method of claim 1, wherein the composition is administered as an oral liquid or injectable solution.

28. A method for treatment of T cell lymphoma comprising administering to a human having a T cell lymphoma a composition comprising a therapeutically effective amount of a salt form of 10-propargyl-10-deazaaminopterin.

29. The method of claim 28, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m.sup.2 per dose.

30. The method of claim 28, wherein the 10-propargyl-10-deazaaminopterin is administered weekly.

31. The method of claim 30, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 30 mg/m.sup.2 per dose.

32. The method of claim 28, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m.sup.2 per dose.

33. The method of claim 28, wherein the 10-propargyl-10-deazaaminopterin is administered biweekly.

34. The method of claim 28, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of 135 to 275 mg/m.sup.2 per dose.

35. The method of claim 28, wherein the T cell lymphoma is peripheral T cell lymphoma.

36. The method of claim 28, wherein the T cell lymphoma is cutaneous T cell lymphoma.

37. The method of claim 36, wherein the cutaneous T cell lymphoma is Mycosis fungoides/Sezary syndrome.

38. The method of claim 28, wherein the T cell lymphoma is selected from the group consisting of: lymphoblastic lymphomas in which the malignancy occurs in primitive lymphoid progenitors from the thymus; mature or peripheral T cell neoplasms selected from the group consisting of T cell prolymphocytic leukemia; T-cell granular lymphocytic leukemia; aggressive NK-cell leukemia; cutaneous T cell lymphoma; anaplastic large cell lymphoma, T cell type; enteropathy-type T cell lymphoma; Adult T-cell leukemia/lymphoma including those associated with HTLV-1; angioimmunoblastic T cell lymphoma; and subcutaneous panniculitic T cell lymphoma; and peripheral T cell lymphomas that initially involve a lymph node paracortex and never grow into a true follicular pattern.

39. The method of claim 28, wherein the T cell lymphoma is relapsed or refractory T cell lymphoma.

40. The method of claim 28, wherein the T cell lymphoma is lymphoblastic lymphoma in which the malignancy occurs in primitive lymphoid progenitors from the thymus.

41. The method of claim 28, wherein the T cell lymphoma is T cell prolymphocytic leukemia.

42. The method of claim 28, wherein the T cell lymphoma is T-cell granular lymphocytic leukemia.

43. The method of claim 28, wherein the T cell lymphoma is aggressive NK-cell leukemia.

44. The method of claim 28, wherein the T cell lymphoma is anaplastic large cell lymphoma, T cell type.

45. The method of claim 28, wherein the T cell lymphoma is enteropathy-type T cell lymphoma.

46. The method of claim 28, wherein the T cell lymphoma is Adult T-cell leukemia/lymphoma including those associated with HTLV-1.

47. The method of claim 28, wherein the T cell lymphoma is angioimmunoblastic T cell lymphoma.

48. The method of claim 28, wherein the T cell lymphoma is subcutaneous panniculitic T cell lymphoma.

49. The method of claim 28, wherein the T cell lymphoma is peripheral T cell lymphoma that initially involves a lymph node paracortex and never grows into a true follicular pattern.

50. The method of claim 28, wherein the 10-propargyl-10-deazaaminopterin is administered in one or more cycles, each cycle comprising administration once weekly for six weeks in an amount of from 30 to 150 mg/m.sup.2 per dose followed by a one week rest.

51. A method for treatment of T cell lymphoma comprising administering to a human having a T cell lymphoma a composition comprising a therapeutically effective amount of 10-propargyl-10-deazaaminopterin, wherein the composition is formulated with 10-propargyl-10-deazaaminopterin in salt form substantially free of 10-deazaaminopterin.

52. The method of claim 51, wherein the 10-propargyl-10-deazaaminopterin is administered in one or more seven-week cycles, each cycle comprising administration once weekly for six weeks in an amount of from 30 to 150 mg/m.sup.2 per dose followed by a one week rest.

53. The method of claim 51, further comprising supplementation with folic acid and vitamin B12.

54. The method of claim 51, wherein the composition is administered as an oral liquid or injectable solution.

55. A method for treatment of T cell lymphoma comprising administering to a human having a T cell lymphoma a composition comprising a therapeutically effective amount of 10-propargyl-10-deazaaminopterin, wherein the composition is formulated with 10-propargyl-10-deazaaminopterin in sodium salt form substantially free of 10-deazaaminopterin.

56. The method of claim 55, wherein the 10-propargyl-10-deazaaminopterin is administered in one or more seven-week cycles, each cycle comprising administration once weekly for six weeks in an amount of from 30 to 150 mg/m.sup.2 per dose followed by a one week rest.

57. The method of claim 55, further comprising supplementation with folic acid and vitamin B12.

58. The method of claim 55, wherein the composition is administered as an oral liquid or injectable solution.
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