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

US 8,299,078 B2
Filed: 10/21/2009
Issued: 10/30/2012
Est. Priority Date: 05/30/2004
Status: Active Grant

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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.

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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/m². In general, the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m²per dose.

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58 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.
- View Dependent Claims (3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
- - 3. The method of claim 1, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m²per 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/m²per dose.
  - 6. The method of claim 3, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m²per 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/m²per 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/m²per 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/m²per dose followed by a one week rest.
  - 26. The method of claim 1, further comprising supplementation with folic acid and vitamin B₁₂.
  - 27. The method of claim 1, wherein the composition is administered as an oral liquid or injectable solution.

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.

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.
- View Dependent Claims (29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50)
- - 29. The method of claim 28, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 275 mg/m²per 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/m²per dose.
  - 32. The method of claim 28, wherein the 10-propargyl-10-deazaaminopterin is administered in an amount of from 30 to 150 mg/m²per 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/m²per 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/m²per 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.
- View Dependent Claims (52, 53, 54)
- - 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/m²per 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.
- View Dependent Claims (56, 57, 58)
- - 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/m²per 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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Current Assignee
Sloan-Kettering Institute For Cancer Research (Memorial Sloan-Kettering Cancer Center)
Original Assignee
Sloan-Kettering Institute For Cancer Research (Memorial Sloan-Kettering Cancer Center)
Inventors
O'Connor, Owen A., Sirotnak, Francis M.
Primary Examiner(s)
Anderson, James D

Application Number

US12/603,117
Publication Number

US 20100120777A1
Time in Patent Office

1,105 Days
Field of Search

None
US Class Current

514/249
CPC Class Codes

A61K 2300/00   Mixtures or combinations of...

A61K 31/519   ortho- or peri-condensed wi...

A61K 31/525   Isoalloxazines, e.g. ribofl...

A61K 31/7068   having oxo groups directly ...

A61P 35/00   Antineoplastic agents

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

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

First Claim

2 Assignments

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Abstract

14 Citations

58 Claims

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