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Claims for Patent: 7,468,363

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Claims for Patent: 7,468,363

Title:Methods for treatment of cancers using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione
Abstract: Methods of treating a specific cancer or amyloidosis are disclosed. Specific methods encompass the administration of 3-(4-amino-1 oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione alone or in combination with a second active ingredient.
Inventor(s): Zeldis; Jerome B. (Princeton, NJ)
Assignee: Celgene Corporation (Summit, NJ)
Application Number:11/102,742
Patent Claims: 1. A method of treating non-Hodgkin's lymphoma, which comprises administering to a patient having non-Hodgkin's lymphoma from about 5 to about 50 mg per day of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt thereof.

2. A method of treating ovarian cancer, which comprises administering to a patient having ovarian cancer from about 5 to about 50 mg per day of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt thereof, and a therapeutically effective amount of cisplatin.

3. A method of treating pancreatic cancer, which comprises administering to a patient having pancreatic cancer from about 5 to about 50 mg per day of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt thereof, and a therapeutically effective amount of gemcitabine.

4. A method of treating renal cancer, which comprises administering to a patient having renal cancer from about 5 to about 50 mg per day of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt thereof.

5. A method of treating amyloidosis, which comprises administering to a patient having amyloidosis from about 5 to about 50 mg per day of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt thereof.

6. A method of treating cutaneous T-Cell lymphoma, which comprises administering to a patient having cutaneous T-Cell lymphoma from about 5 to about 50 mg per day of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione or a pharmaceutically acceptable salt thereof.

7. A method of treating non-Hodgkin's lymphoma, which comprises administering to a patient having non-Hodgkin's lymphoma from about 5 to about 50 mg per day of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt thereof, and a therapeutically effective amount of rituximab.

8. A method of treating ovarian cancer, which comprises administering to a patient having ovarian from about 5 to about 50 mg per day of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt thereof, and a therapeutically effective amount of topotecan.

9. A method of treating non-Hodgkin's lymphoma, which comprises administering to a patient having non-Hodgkin's lymphoma from about 5 to about 50 mg per day of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt thereof, and a therapeutically effective amount of fludarabine.

10. A method of treating cutaneous B-Cell lymphoma, which comprises administering to a patient having cutaneous B-Cell lymphoma from about 5 to about 50 mg per day of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt thereof.

11. A method of treating diffuse large B-Cell lymphoma, which comprises administering to a patient having diffuse large B-Cell lymphoma from about 5 to about 50 mg per day of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt thereof.

12. The method of claim 5, 6, 10 or 11, which further comprises administering a therapeutically effective amount of rituximab.

13. The method of claim 5, 6, 10 or 11, which further comprises administering a therapeutically effective amount of fludarabine;

14. The method of any one of claims 1 and 2 to 11, wherein the compound is 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2 ,6-dione.

15. The method of any one of claims 1 and 2 to 11, wherein the compound is a pharmaceutically acceptable salt.

16. A method of treating amyloidosis, which comprises administering to a patient having amyloidosis from about 5 to about 50 mg per day of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt thereof, and a therapeutically effective amount of melphalan or dexamethasone.

17. A method of treating non-Hodgkin's lymphoma, which comprises administering to a patient having non-Hodgkin's lymphoma from about 5 to about 50 mg per day of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt thereof, and a therapeutically effective amount of a protein kinase inhibitor.

18. The method of any one of claims 1, 2 to 11, 16 or 17, wherein the compound is administered orally.

19. The method of claim 18, wherein the compound is administered in the form of a capsule or tablet.

20. The method of any one of claims 1, 2 to 11, 16 or 17, wherein the compound is administered in an amount of from about 5 to about 25 mg per day.

21. The method of claim 20, wherein the compound is administered cyclically.

22. The method of claim 21, wherein one cycle comprises four to six weeks.

23. The method of claim 21, wherein one cycle comprises the administration of the compound for 21 days followed by seven days rest.

24. The method of claim 21, wherein the compound is administered in an amount of from about 5 to about 25 mg per day for 21 days followed by seven days rest in a 28 day cycle.
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