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Last Updated: March 28, 2024

Claims for Patent: 8,012,465


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Summary for Patent: 8,012,465
Title:Methods for treating renal cell carcinoma
Abstract: Methods for treating renal cell carcinoma using low doses of IL-2 are disclosed. In particular, the invention relates to methods of treating metastatic renal cell carcinoma in patients who are renally impaired and/or intolerant of high dose IL-2 therapy. The therapeutic regimen described herein significantly inhibits tumor growth with reduced toxicity and adverse side effects compared to high dose IL-2 therapy.
Inventor(s): Elias; Laurence (Emeryville, CA), Witherell; Gary (Emeryville, CA)
Assignee: Novartis Vaccines and Diagnostics, Inc. (Emeryville, CA)
Application Number:12/460,991
Patent Claims:1. A method for treating a human patient having renal cell carcinoma, the method comprising: a) first, administering a dose of 18 MIU of an IL-2 mutein per day for 5 days during one week; b) second, administering a dose of 9 MIU of the IL-2 mutein per day for 2 days followed by administering a dose of 18 MIU of the IL-2 mutein per day for 3 days during each week, repeated for 5 weeks; c) third, administering no IL-2 mutein for 3 weeks; d) fourth, administering a dose of 9 MIU of the IL-2 mutein per day for 5 days of each week, repeated for 6 weeks; and e) fifth, administering no IL-2 mutein for 3 weeks, wherein said IL-2 mutein is administered by subcutaneous, intraperitoneal, intramuscular, intravenous, oral, pulmonary, nasal, topical, or transdermal administration, or by infusion or suppositories.

2. The method of claim 1, wherein said IL-2 mutein is recombinantly produced IL-2 comprising an amino acid sequence having at least 70% sequence identity to the amino acid sequence of human IL-2.

3. The method of claim 1, wherein said IL-2 mutein comprises an amino acid sequence having at least 80% sequence identity to the amino acid sequence of human IL-2.

4. The method of claim 1, wherein said IL-2 mutein comprises an amino acid sequence having at least 90% sequence identity to the amino acid sequence of human IL-2.

5. The method of claim 1, wherein said IL-2 mutein comprises an amino acid sequence having at least 95% sequence identity to the amino acid sequence of human IL-2.

6. The method of claim 1, wherein said IL-2 mutein is des-alanyl-1, serine-125 human interleukin-2 (aldesleukin).

7. The method of claim 1, wherein said renal cell carcinoma is metastatic.

8. The method of claim 1, wherein multiple cycles of the method of treatment are administered to said subject for a time period sufficient to effect at least a partial tumor response.

9. The method of claim 1, further comprising multiple cycles of a treatment comprising: a) administering a dose of 9 MIU of the IL-2 mutein per day, in 1-3 doses a day, for 3-6 days a week, repeated for 1-24 weeks; and b) administering no IL-2 mutein for 1-4 weeks; administered to said subject for a time period sufficient to effect at least a partial tumor response.

10. The method of claim 8, wherein the time period is at least 6 months.

11. The method of claim 9, wherein the time period is at least 6 months.

12. The method of claim 8, wherein the time period is at least 12 months.

13. The method of claim 9, wherein the time period is at least 12 months.

14. The method of claim 8, wherein a complete tumor response is effected.

15. The method of claim 9, wherein a complete tumor response is effected.

16. The method of claim 1, wherein said IL-2 mutein is administered subcutaneously.

17. The method of claim 1, wherein said patient is renally impaired.

18. The method of claim 1, wherein said patient is intolerant of high dose IL-2 treatment.

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