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Claims for Patent: 7,887,836

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Claims for Patent: 7,887,836

Title:Compositions and methods for treating lymphoma
Abstract: This invention provides methods for treating neoplasias in a mammal. In particular, the invention provides methods for treating various types of lymphomas, including relapsed forms of non-Hodgkin's Lymphoma. These methods involve the administration of liposome-encapsulated vinca alkaloids, e.g., vincristine, to a mammal with a lymphoma.
Inventor(s): Sarris; Andreas H. (Athens, GR), Cabanillas; Fernando (San Juan, PR), Logan; Patricia M. (Grand Forks, CA), Burge; Clive T. R. (Brentwood Bay, CA), Goldie; James H. (Vancouver, CA), Webb; Murray S. (N. Vancouver, CA)
Assignee: Hana Biosciences, Inc. (South San Francisco, CA) Board of Regents, The University of Texas System (Austin, TX)
Application Number:12/075,013
Patent Claims: 1. A method for treating a cancer selected from the group consisting of lymphoma, leukemia and myeloma in a human, said method comprising administering to said human a composition comprising liposome-encapsulated vincristine at a dosage of about 1.5 mg/m.sup.2 to about 2.4 mg/m.sup.2, wherein the liposome comprises sphingomyelin and cholesterol in a ratio of about 75/25 (mol % sphingomyelin/mol % cholesterol) to about 50/50 (mol % sphingomyelin/mol % cholesterol) and vincristine at a concentration of about 0.10-0.50 mg/ml.

2. A method for treating lymphoma, leukemia or myeloma in a human, said method comprising administering to said human a composition comprising liposome-encapsulated vincristine at a dosage of at least about 2.0 mg/m.sup.2 to about 2.4 mg/m.sup.2, wherein the liposome comprises sphingomyelin and cholesterol in a ratio of about 55/45 (mol % sphingomyelin/mol % cholesterol) and vincristine at a concentration of about 0.10-0.50 mg/ml.

3. The method of claim 1 or 2, wherein the liposome-encapsulated vincristine comprises vincristine at a concentration of about 0.15 to about 0.20 mg/ml.

4. The method of claim 1 or 2, wherein the liposome-encapsulated vincristine comprises vincristine at a concentration of about 0.16 mg/ml.

5. The method of claim 1, wherein the liposome-encapsulated vincristine is administered to the human at a dose of about 2.0 mg/m.sup.2 to about 2.4 mg/m.sup.2.

6. The method of claim 1 or 2, wherein the lymphoma, leukemia or myeloma relapsed or refractory.

7. The method of claim 1 or 2, wherein the lymphoma is non-Hodgkin's lymphoma (NHL).

8. The method of claim 1 or 2, wherein the leukemia is Acute Lymphocytic Leukemia (ALL).

9. The method of claim 1, wherein the liposomes comprise sphingomyelin and cholesterol in a ratio of about 70/30 (mol % sphingomyelin/mol % cholesterol) to about 55/45 (mol % sphingomyelin/mol % cholesterol).

10. The method of claim 1, wherein the liposomes comprise sphingomyelin and cholesterol in a ratio of about 55/45 (mol % sphingomyelin/mol % cholesterol).

11. The method of claim 1 or 2, wherein said liposome-encapsulated vincristine is administered parenterally.

12. The method of claim 1 or 2, wherein said liposome-encapsulated vincristine is administered systemically by intravenous infusion.

13. The method of claim 12, wherein the liposome-encapsulated vincristine is administered to the human by intravenous infusion over about 30 to about 90 minutes.

14. The method of claim 12, wherein the liposome-encapsulated vincristine is administered to the human 1 by intravenous infusion over about 60 minutes.

15. The method of claim 12, wherein the liposome-encapsulated vincristine is administered to the human intravenously over about 60 minutes about every 7 to about 21 days.

16. The method of claim 12, wherein the liposome-encapsulated vincristine is administered to the human about every 1 to about 28 days.

17. The method of claim 1 or 2, wherein the liposome-encapsulated vincristine is administered to the human about every 7 to about 21 days.

18. The method of claim 1 or 2, wherein the liposome-encapsulated vincristine is administered to the human about every 14 days.

19. The method of claim 1 or 2, wherein the liposome-encapsulated vincristine is administered to the human about every 7 days.

20. The method of claim 1 or 2, wherein said liposome-encapsulated vincristine is co-administered with at least one additional cancer therapy.

21. The method of claim 20, wherein said additional cancer therapy is selected from the group consisting of radiation therapy, bone marrow transplantation, hormone therapy, surgery, cyclophosphamide, doxorubicin, prednisone, a taxane, a camptothecin, a podophyllins, and combinations thereof.

22. The method of claim 20, wherein said additional cancer therapy is an anti-tumor antibody.

23. The method of claim 20, wherein said additional cancer therapy is an antisense drug or an anti-tumor vaccine.

24. The method of claim 1 or 2, wherein said liposome-encapsulated vincristine is co-administered with a treatment for neurotoxicity.

25. The method of claim 1 or 2, wherein about 3.0 to about 6.0 mg of vincristine is administered to the human.

26. The method of claim 20, wherein said additional cancer therapy is a taxane.

27. The method of claim 26, wherein said taxane is a liposomal taxane.

28. The method of claim 1, wherein said vincristine is vincristine sulfate.

29. The method of claim 1 or 2, wherein said liposomal-encapsulated vincristine is co-administered with cyclophosphamide, doxorubicin and prednisone.

30. The method of claim 2, further comprising the steps of: (a) mixing a first solution comprising 1 mg/ml to 5 mg/ml vincristine sulfate at a pH of 3.5 to 5.5 with a second solution comprising empty liposomes in a buffer at a pH of about 4.0, wherein the liposomes comprise sphingomyelin and cholesterol in a ratio of about 55/45 (mol % sphingomyelin/mol % cholesterol); and (b) adding a third solution comprising an alkaline phosphate buffer having a pH sufficient to raise the pH of said mixture prepared in step (a) to produce said liposome-encapsulated vincristine prior to administration to said human.
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