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Claims for Patent: 6,723,338

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Claims for Patent: 6,723,338

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. (Houston, TX), Cabanillas; Fernando (Houston, TX), Logan; Patricia M. (Vancouver, CA), Burge; Clive T. R. (Brentwood Bay, CA), Goldie; James H. (Vancouver, CA), Webb; Murray S. (Delta, CA)
Assignee: Inex Pharmaceuticals Corporation (Burnaby, CA) Board of Regents, The University of Texas System (Austin, TX)
Application Number:09/541,436
Patent Claims: 1. A method of treating a relapsed cancer in a human, said method comprising administering to said human a pharmaceutical composition comprising liposome-encapsulated vinctistine, wherein said relapsed cancer is a lymphoma or leukemia, and wherein said human has previously undergone at least one multi-agent combination regime.

2. The method of claim 1, wherein said relapsed cancer is a non-Hodgkin's Lymphoma.

3. The method of claim/wherein said non-Hodgkin's Lympho a is a member selected from the group consisting of low grade non-Hodgkin's Lymphoma, intermediate grade non-Hodgkin's Lymphoma, follicular lymphom, large cell lymphoma, B-cell lymphoma, T-celi lymphorna, Mantle cell lymphoma, Burkitt's lynphoma, NK cell lymphoma, and acute lymphoblastic lymphoma.

4. The method of claim 1, wherein said liposome comprises distearoylphosphatidylcholine.

5. The method of claim 4, wherein said liposome further comprises cholesterol.

6. The method of claim 1, wherein said liposome comprises sphingomyclin.

7. The method of claim 6, wherein said liposome further comprises cholesterol.

8. The method of claim 1, wherein said liposome comprises a pH gradient.

9. The method of claim 8, wherein the pH gradient is such that the pH is lower at the interior of said liposome than at the exterior of said liposome.

10. The method of claim 1, wherein said at least one multi-agent combination regime comprised administration of a free-form vinca-alkaloid.

11. The method of claim 10, wherein said free-form vinca alkaloid is a member selected from the group consisting of vincristine, vinblastine, vindesine, and vinorelbine.

12. The method of claim 1, wherein said at least one multi-agent combination regime comprised administration of an anffiacycline-containing combination regimen.

13. The method of claim 12, wherein said anthracycline is doxorubicin.

14. The method of claim 1, wherein said human has exhibited a partial response or a complete response to said multi-agent combination regime prior to the relapse of said cancer.

15. The method of claim 1, wherein said relapse is a second relapse.

16. The method of claim 1, wherein said liposome-encapsulated vincristine is administered systemically by intravenous delivery.

17. The method of claim 1, wherein said liposome-encapsulated vincristine is co-administered with at least one additional chemotherapeutic agent.

18. The method of claim 17, wherein said at least one additional chemotherapeutic agent is a member selected from the group consisting of cyclophosphamide, doxorubicin, prednisone, and combinations thereof.

19. The method of claim 1, wherein said liposome-encapsulated vincristine is co-administered with at least one additional anti-tumor agent.

20. The method of claim 19, wherein said additional anti-tumor agent is a monoclonal antibody.

21. The method of claim 20, wherein said monoclonal antibody is a member selected from the group consisting of Rituximab, iodine 131 (131I) Lym-1, and iodine 131 (131I) tositumomab.

22. The method of claim 19, wherein said additional anti-tumor agent is an antisense drug or an anti-tumor vaccine.

23. The method of claim 1, wherein said vincristine is administered at a dosage of between about 1.4 to about 2.4 mg/m2 to said human.

24. The method of claim 1, wherein said vincristine is administered to said patient once every 7-21 days.

25. The method of claim 24, wherein said vincristine is administered to said patient once every 14 days.

26. The method of claim 1, wherein said relapsed cancer is a lymphoma.

27. The method of claim 1, wherein said relapsed cancer is a leukemia.
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