US2023340148A1PendingUtilityA1

Method for treating a gd2 positive cancer

75
Assignee: APEIRON BIOLOGICS AGPriority: Jun 18, 2012Filed: Sep 19, 2022Published: Oct 26, 2023
Est. expiryJun 18, 2032(~5.9 yrs left)· nominal 20-yr term from priority
C07K 16/3084C07K 14/55A61K 31/485A61K 39/39533A61K 45/06C07K 16/28A61K 39/39558A61K 2039/505C07K 2317/24C07K 2317/732C07K 2317/734C07K 2319/00A61P 35/00A61P 43/00A61K 2039/54A61K 2039/545C07K 2317/76
75
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Claims

Abstract

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.

Claims

exact text as granted — not AI-modified
1 - 39 . (canceled) 
     
     
         40 . A method for treating a patient with a GD2 positive cancer comprising: administering a preparation comprising an anti-GD2 antibody to the patient as a continuous intravenous infusion over 24 hours per day at a daily dose of 1 to 25 mg/m 2  for at least 7 consecutive days and in a dose of 50 to 150 mg/m 2 /cycle wherein the anti-GD2 antibody is ch14.18/CHO or ch14.18/SP2/0. 
     
     
         41 . The method of  claim 40 , wherein the preparation is administered to the patient for 7, 8, 9, 10, 11, 12, 13, 14, or 15 consecutive days. 
     
     
         42 . The method of  claim 40 , wherein the preparation is administered to the patient at a daily dose of 7, 10, 15, or 20 mg/m 2  of the anti-GD2 antibody. 
     
     
         43 . The method of  claim 40 , wherein the preparation is administered to the patient at a daily dose of 10 mg/m 2  of the anti-GD2 antibody for 10 consecutive days. 
     
     
         44 . The method of  claim 40 , wherein the preparation is administered to the patient in a dose of 50, 60, 75, 80, 100, 120, or 150 mg/m 2 /cycle of the anti-GD2 antibody. 
     
     
         45 . The method of  claim 40 , wherein the preparation is administered to the patient in a dose of 100 mg/m 2 /cycle of the anti GD2 antibody. 
     
     
         46 . The method of  claim 40 , wherein the anti-GD2 antibody is ch14.18/CHO. 
     
     
         47 . The method of  claim 40 , wherein the anti-GD2 antibody is ch14.18/SP2/0. 
     
     
         48 . The method of  claim 40 , wherein the preparation is administered to the patient for 2 or more treatment cycles. 
     
     
         49 . The method of  claim 40 , wherein the preparation is administered to the patient for treatment cycles, wherein each treatment cycle is of 35 days. 
     
     
         50 . The method of  claim 40 , further comprising administering IL-2 and/or GM-CSF or another cytokine, wherein administering the IL-2 and/or GM-CSF or another cytokine precedes and/or at least partially accompanies a period of time of the administration of the preparation. 
     
     
         51 . The method of  claim 50 , wherein IL-2 is administered over 10 days by subcutaneous administration at a dose of 6×10 6  IU/m 2 /day. 
     
     
         52 . The method of  claim 50 , wherein the IL-2 is administered over two 5 day periods, wherein a first 5 day period precedes the period of time of the administration of the preparation; and a second 5 day period accompanies the first 5 days of the administration of the preparation. 
     
     
         53 . The method of  claim 40 , wherein an administration period of the preparation is followed by an administration of isotretinoin or another retinoid. 
     
     
         54 . The method of  claim 53 , wherein the isotretinoin is administered orally over 14 days at a dose of 160 mg/m 2 /day. 
     
     
         55 . The method of  claim 40 , further comprising administering morphine and/or an analgesic to the patient. 
     
     
         56 . The method of  claim 55 , wherein a daily morphine dose administered during one or more days of continuous intravenous infusion of the preparation and/or of all morphine treatment days is lower than a daily morphine dose during a non-continuous administration of the preparation. 
     
     
         57 . The method of  claim 55 , wherein morphine is administered on some but not all days on which the preparation is administered. 
     
     
         58 . The method of  claim 55 , wherein a morphine dose per treatment cycle administered during one or more treatment cycles comprising the continuous intravenous infusion of the preparation is lower than a standard morphine dose per treatment cycle in a non-continuous infusion schedule of the preparation. 
     
     
         59 . The method of  claim 55 , wherein a morphine dose of overall treatment time is lower than a standard morphine dose of a overall treatment time in a non-continuous infusion schedule of the preparation. 
     
     
         60 . The method of  claim 55 , wherein a morphine dose administered during one or more hours or days of continuous intravenous infusion of the preparation and/or of all morphine treatment hours or days is lower than 50 mcg/kg/h. 
     
     
         61 . The method of a  claim 55 , wherein a daily morphine dose administered during one or more days of continuous intravenous infusion of the preparation and/or of all morphine treatment days is lower than 0.9 mg/kg/day. 
     
     
         62 . The method of  claim 55 , 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. 
     
     
         63 . The method of  claim 40 , 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. 
     
     
         64 . The method of  claim 63 , wherein the patient suffers from primary refractory or relapsed high risk-neuroblastoma or from minimal residual disease in high-risk neuroblastoma.

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