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 Stage IIB or Stage III melanoma which has been surgically removed, which comprises administering to the patient a first dose of 6.0 micrograms/kg of PEG 12000 interferon alpha-2b once a week for eight weeks, and then administering to the patient a second dose of 3.0 or less micrograms/kg of PEG 12000 interferon alpha-2b once a week for the remainder of a five year treatment period.
2. The method of claim 1 , wherein the patient is a treatment-naive patient.
3. The method of claim 1 , wherein the patient is a treatment-experienced patient.
4. The method of claim 3 , wherein the treatment-experienced patient has been previously treated with immunotherapy.
5. The method of claim 4 , wherein the treatment-experienced patient has been previously treated with interferon alpha.
6. The method of claim 3 , wherein the treatment-experienced patient has been previously treated with dacarbazine.
7. The method of claim 1 , wherein the patient has N1 regional lymph node metastasis detected at elective lymph node dissection with clinically inapparent regional lymph node metastasis.
8. The method of claim 1 , wherein the patient has Stage IIB melanoma.
9. The method of claim 1 , wherein the patient has Stage III melanoma.
10. The method of claim 1 , wherein the patient has clinically apparent N1 regional lymph node involvement synchronous with primary melanoma of T1-4.
11. A method of treating a patient having Stage III melanoma which has been surgically removed, which comprises administering to the patient a first dose of 6.0 micrograms/kg of PEG 12000 interferon alpha-2b once a week for eight weeks, and then administering to the patient a second dose of PEG 12000 interferon alpha-2b once a week for the remainder of a total treatment period of five years, wherein the second dose starts at 3.0 micrograms/kg and is then reduced to 2.0 micrograms/kg.
12. The method of claim 11 , wherein the second dose is further reduced to 1.0 micrograms/kg.
13. The method of claim 11 , wherein the patient is a treatment-naive patient.
14. The method of claim 11 , wherein the patient is a treatment-experienced patient.
15. The method of claim 14 , wherein the treatment-experienced patient has been previously treated with immunotherapy.
16. The method of claim 14 , wherein the treatment-experienced patient has been previously treated with interferon alpha.
17. The method of claim 11 , wherein the patient has N1 regional lymph node metastasis detected at elective lymph node dissection with clinically inapparent regional lymph node metastasis.