Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin

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 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 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 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 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 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 2 per dose followed by a one week rest.

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