Method for treating a GD2 positive cancer
The present invention relates to a method for treating a GD2 positive cancer by administering a preparation comprising an anti-GD2 antibody to a patient as a continuous intravenous infusion over 24 hours per day.
1. A method for treating a patient with a GD2 positive cancer comprising:
administering a preparation comprising a anti-GD2 antibody to the patient as a continuous intravenous infusion over 24 hours per day at a daily dose of 10 mg/m 2 for 10 consecutive days, wherein the anti-GD2 antibody is ch14.18/CHO or ch14.18/SP2/0; and
administering IL-2, wherein administering the IL-2 precedes and/or at least partially accompanies the period of time of the administration of the preparation comprising the anti-GD2 antibody.
2. The method of claim 1 , wherein the preparation is administered to the patient in a dose of 100 mg/m 2 /cycle of the anti GD2 antibody.
3. The method of claim 1 , wherein the anti-GD2 antibody is ch14.18/CHO.
4. The method of claim 1 , wherein the preparation comprising the anti-GD2 antibody is administered to the patient for 2 or more treatment cycles.
5. The method of claim 4 , wherein the preparation comprising the anti-GD2 antibody is administered to the patient for 5 treatment cycles, wherein each treatment cycle is of 35 days.
6. The method of claim 1 , wherein the preparation comprising the anti-GD2 antibody is ch14.18/CHO and is administered to the patient in a dose of 10 mg/m 2 /day of the anti-GD2 antibody for 10 consecutive days for 2 or more treatment cycles.
7. The method of claim 1 , wherein the anti-GD2 antibody is ch14.18/SP2/0 and is administered to the patient in a dose of 10 mg/m 2 /day of the anti-GD2 antibody for 10 consecutive days for 2 or more treatment cycles.
8. The method of claim 1 , wherein the GD2 positive cancer is neuroblastoma, glioblastoma, medulloblastoma, astrocytoma, melanoma, small-cell lung cancer, desmoplastic small round cell tumor, osteosarcoma, rhabdomyosarcoma, or another soft tissue sarcoma.
9. The method of claim 8 , wherein the patient suffers from primary refractory or relapsed high risk-neuroblastoma or from minimal residual disease in high-risk neuroblastoma.
10. The method of claim 1 , wherein the anti-GD2 antibody is ch14.18/SP2/0.
11. The method of claim 1 , wherein the administration period of the preparation comprising the anti-GD2 antibody is followed by an administration of isotretinoin or another retinoid.
12. The method of claim 11 , wherein the isotretinoin is administered orally over 14 days at a dose of 160 mg/m 2 /day.
13. The method of claim 1 , wherein the IL-2 is administered over 10 days by subcutaneous administration at a dose of 6×10 6 IU/m 2 /day.
14. The method of claim 13 , wherein the IL-2 is administered over two 5 day periods, wherein the first 5 day period precedes the period of time of the administration of the preparation comprising the anti-GD2 antibody; and the second 5 day period accompanies the first 5 days of the administration of the preparation comprising the anti-GD2 antibody.
15. The method of claim 1 , further comprising administering morphine and/or an analgesic to the patient.
16. The method of claim 15 , wherein a daily morphine dose administered during one or more days of continuous intravenous infusion of the preparation comprising the anti-GD2 antibody and/or of all morphine treatment days is lower than the daily morphine dose during non-continuous administration of the preparation comprising the anti-GD2 antibody.
17. The method of claim 15 , wherein morphine is administered on some but not all days on which the preparation comprising the anti-GD2 antibody is administered.
18. The method of claim 15 , wherein a morphine dose per treatment cycle administered during one or more treatment cycles comprising the continuous intravenous infusion of the preparation comprising the anti-GD2 antibody is lower than a standard morphine dose per treatment cycle in a non-continuous infusion schedule of the preparation comprising the anti-GD2 antibody.
19. The method of claim 15 , wherein a morphine dose of the overall treatment time is lower than a standard morphine dose of the overall treatment time in a non-continuous infusion schedule of the preparation comprising the anti-GD2 antibody.
20. The method of claim 15 , wherein a morphine dose administered during one or more hours or days of continuous intravenous infusion of the preparation comprising the anti-GD2 antibody and/or of all morphine treatment hours or days is lower than 50 mcg/kg/h, or lower than 30 mcg/kg/h.
21. The method of a claim 15 , wherein the daily morphine dose administered during one or more days of continuous intravenous infusion of the preparation comprising the anti-GD2 antibody and/or of all morphine treatment days is lower than 0.9, 0.72, 0.48, 0.38, 0.4375, or 0.205 mg/kg/day.
22. The method of claim 15 , wherein a dose of one or more analgesics is reduced within an overall treatment time, within a treatment cycle, during a anti-GD2 antibody treatment period within a treatment cycle, from one anti-GD2 antibody treatment day to a next anti-GD2 antibody treatment day within a treatment cycle, and/or from one treatment cycle to a next treatment cycle.