Melanoma therapy
View Patent ↗Methods for treating treatment-naive as well as treatment-experienced patients having melanoma to increase the progression-free survival time involving administering a therapeutically effective amount of pegylated interferon-alpha, e.g., preferably pegylated interferon alpha-2b, as adjuvant therapy to definitive surgery are disclosed.
1. A method of treating a patient having melanoma which has been surgically removed, which comprises administering to such a patient a therapeutically effective weekly dose of PEG 12000 interferon alpha for a time period sufficient to increase progression-free survival time;
wherein the therapeutically effective weekly dose of PEG 12000 interferon alpha administered is selected from the group consisting of about 3.0 micrograms/kg to 9.0 micrograms/kg of PEG 12000 interferon alpha-2b and about 200 micrograms to 250 micrograms of PEG 12000 interferon alpha-2a.
2. The method of claim 1 wherein the patient is a treatment-naive patient.
3. The method of claim 2 wherein the treatment-naive patient is one having newly diagnosed melanoma.
4. The method of claim 1 wherein the patient is a treatment-experienced patient.
5. The method of claim 4 wherein the treatment experienced patient is intolerant to interferon alpha or resistant to interferon alpha.
6. The method of claim 1 wherein the time period is at least about 24 months.
7. The method of claim 1 wherein the therapeutically effective weekly dose of PEG 12000 interferon alpha administered is about 3.0 micrograms/kg to 9.0 micrograms/kg of PEG 12000 interferon alpha-2b.
8. The method of claim 7 wherein the therapeutically effective weekly dose of PEG 12000 interferon alpha-2b is about 4.5 to about 6.5 micrograms/kg of PEG 12000 interferon alpha-2b.
9. The method of claim 8 wherein the therapeutically effective weekly dose of PEG 12000 interferon alpha-2b is about 5.5 to about 6.5 micrograms/kg of PEG 12000 interferon alpha-2b.
10. The method of claim 9 wherein the therapeutically effective weekly dose of PEG 12000 interferon alpha-2b is about 6.0 micrograms/kg of PEG 12000 interferon alpha-2b.
11. The method of claim 10 further comprising a dose reduction step such that 6.0 micrograms/kg of PEG 12000 interferon alpha-2b is administered once a week for eight weeks, and
then 3.0 or less micrograms/kg of PEG 12000 interferon alpha-2b is administered once a week for the remainder of a five year treatment period.
12. The method of claim 11 wherein the dose reduction step is to 3 micrograms/kg of PEG 12000 interferon alpha-2b once a week for the remainder of the five year treatment period.
13. The method of claim 12 further comprising a second dose reduction step to 2 micrograms/kg of PEG 12000 interferon alpha-2b once a week for the remainder of the five year treatment period.
14. The method of claim 13 further comprising a third dose reduction step to 1 microgram/kg of PEG 12000 interferon alpha-2b once a week for the remainder of the five year treatment period.
15. The method of claim 1 wherein the therapeutically effective weekly dose of PEG 12000 interferon alpha administered is about 200 micrograms to 250 micrograms of PEG 12000 interferon alpha-2a.
16. A method of treating a patient having cutaneous melanoma which has been surgically removed which comprises administering to said patient an effective amount of PEG 12000 interferon alpha once a week for a time period sufficient to increase progression-free survival time;
wherein the effective amount of PEG 12000 interferon alpha administered once a week is selected from the group consisting of about 3.0 micrograms/kg to 9.0 micrograms/kg of PEG 12000 interferon alpha-2b and about 200 micrograms to 250 micrograms of PEG 12000 interferon alpha-2a.
17. The method of claim 16 wherein the effective amount of PEG 12000 interferon alpha administered once a week is about 3.0 micrograms/kg to 9.0 micrograms/kg of PEG 12000 interferon alpha-2b.
18. The method of claim 17 wherein the therapeutically effective weekly dose of PEG 12000 interferon alpha-2b is about 4.5 to about 6.5 micrograms/kg of PEG 12000 interferon alpha-2b.
19. The method of claim 18 wherein the therapeutically effective weekly dose of PEG 12000 interferon alpha-2b is about 5.5 to about 6.5 micrograms/kg of PEG 12000 interferon alpha-2b.
20. The method of claim 19 wherein the therapeutically effective weekly dose of PEG 12000 interferon alpha-2b is about 8.0 micrograms/kg of PEG 12000 interferon alpha-2b.
21. The method of claim 20 further comprising a dose reduction step such that 6.0 micrograms/kg of PEG 12000 interferon alpha-2b is administered once a week for eight weeks, and
then 3.0 or less micrograms/kg of PEG 12000 interferon alpha-2b is administered once a week for the remainder of a five year treatment period.
22. The method of claim 21 wherein the dose reduction step is to 3 micrograms/kg of PEG 12000 interferon alpha-2b once a week for the remainder of the five year treatment period.
23. The method of claim 22 further comprising a second dose reduction step to 2 micrograms/kg of PEG 12000 interferon alpha-2b once a week for the remainder of the five year treatment period.
24. The method of claim 23 further comprising a third dose reduction step to 1 microgram/kg of PEG 12000 interferon alpha-2b once a week for the remainder of the five year treatment period.
25. The method of claim 16 wherein the effective amount of PEG 12000 interferon alpha administered once a week is about 200 micrograms to 250 micrograms of PEG 12000 interferon alpha-2a.
26. The method of claim 16 wherein the time period is at least about 100 weeks.
27. A method of treating a patient having cutaneous melanoma which comprises administering to such a patient about 3.0 micrograms/kg to about 9.0 micrograms/kg of PEG 12000 interferon alpha-2b once a week for a time period sufficient to increase the progression-free survival time.
28. The method of claim 27 wherein the time period is about 100 weeks.
29. The method of claim 27 wherein about 4.5 to about 6.5 micrograms/kg of PEG 12000 interferon alpha-2b is administered once a week.
30. The method of claim 29 wherein about 5.5 to about 6.5 micrograms/kg of PEG 12000 interferon alpha-2b is administered once a week.
31. The method of claim 30 wherein about 6.0 micrograms/kg of PEG 12000 interferon alpha-2b is administered once a week.
32. The method of claim 31 further comprising a dose reduction step such that 6.0 micrograms/kg of PEG 12000 interferon alpha-2b is administered once a week for eight weeks, and
then 3.0 or less micrograms/kg of PEG 12000 interferon alpha-2b is administered once a week for the remainder of a five year treatment period.
33. The method of claim 32 wherein the dose reduction step is to 3 micrograms/kg of PEG 12000 interferon alpha-2b once a week for the remainder of a five year treatment period.
34. The method of claim 33 further comprising a second dose reduction step to 2 micrograms/kg of PEG 12000 interferon alpha-2b once a week for the remainder of the five year treatment period.
35. The method of claim 34 further comprising a third dose reduction step to 1 microgram/kg of PEG 12000 interferon alpha-2b once a week for the remainder of the five year treatment period.