PREPARATIONS AND METHODS FOR TREATING A GD2 POSITIVE CANCER
The present invention relates to preparations and methods for treating a GD2 positive cancer by administering a preparation comprising a chimeric or humanized anti-GD2 antibody to a patient, wherein the patient is not concomitantly treated with Interleukin-2 (IL-2wherein a GD2 positive cancer is treated in the patient. Furthermore, the invention relates to preparations and methods for the treatment of a GD2 positive cancer in a patient, wherein a preparation comprising an anti-GD2 antibody is administered to the patient as a continuous infusion, without concomitantly administering IL-2. The present invention further relates to preparations and methods for the treatment of a GD2 positive cancer in a patient, wherein the one or more anti-GD2 antibody treatment periods is/are preceded, accompanied, and/or followed by one or more treatment periods with a retinoid.
1 - 27 . (canceled)
28 . A method of treating a high-risk neuroblastoma in a patient, the method comprising:
administering to the patient a ch14.18/CHO chimeric anti-GD2 antibody or a ch14.18/SP2/0 chimeric anti-GD2 antibody, over 4 consecutive days in a cycle having from 24 to 32 days, for at least 1 and up to a total of 5 cycles, wherein the patient is administered 60 to 75 mg/m 2 of the anti-GD2 antibody in each cycle.
29 . The method of claim 28 , wherein the patient is a pediatric patient.
30 . The method of claim 28 , wherein the patient is administered 70 mg/m 2 of the anti-GD2 antibody in each cycle.
31 . The method of claim 28 , wherein the administering of the anti-GD2 antibody is over 10 or more hours per day up to 20 hours per day.
32 . The method of claim 28 , wherein:
in each of cycles 1, 3, and 5 of the 5 cycles, the administering of the anti-GD2 antibody is on the fourth day to the seventh day of each of the cycles 1, 3, and 5; and
in each of cycles 2 and 4 of the 5 cycles, the administering of the anti-GD2 antibody is on the eighth day to the eleventh day of each of the cycles 2 and 4.
33 . The method of claim 32 , further comprising:
administering retinoic acid in each of cycles 1, 3, and 5 of the 5 cycles on the eleventh day to the twenty-fourth day of the cycles 1, 3, and 5;
administering retinoic acid in each of cycles 2 and 4 of the 5 cycles on the fifteenth day to the twenty-eighth day of the cycles 2 and 4;
wherein the retinoic acid is administered orally twice daily for a total dose of 160 mg/m 2 /day; and
administering GM-CSF in each of cycles 1, 3, and 5 of the 5 cycles on the first day to the fourteenth day of the cycles 1, 3, and 5, wherein the GM-CSF is administered at a dose of 250 μg/m 2 /day by subcutaneous injection or by IV infusion over 2 hours.
34 . A method of treating a high-risk neuroblastoma in a patient, the method comprising:
administering to the patient a ch14.18/SP2/0 chimeric anti-GD2 antibody at a dose of 15 to 20 mg/m 2 /day as an intravenous infusion over 10 or more hours per day up to 20 hours per day over 4 consecutive days in a cycle having from 24 to 32 days, for at least 1 and up to a total of 5 cycles.
35 . The method of claim 34 , wherein the patient is a pediatric patient.
36 . The method of claim 34 , wherein the dose is 17.5 mg/m 2 /day.