18
Participants
Start Date
December 31, 2015
Primary Completion Date
May 31, 2017
Study Completion Date
May 31, 2017
L19-IL2
"Patients receive a schedule of 1 x 30 Gy, 3 x 15-20 Gy; 5 x 12 Gy; 8 x 7.5 Gy; to the 80 % or 100 % isodose.~Step -1: Toxicity of 10 Mio IU of L19-IL2 (n=3-6)10 Mio IU of L19-IL2 (max. 6 cycles) via i.v. bolus injection.~Toxicity scored at every i.v. drug administration and on day 7, 14 and 21. Step 1: Toxicity of 15 Mio IU of L19-IL2 (n=3-6)(max. 6 cycles) via i.v. bolus injection.~Step 2: Toxicity of 22.5 Mio IU of L19-IL2 (n=3-6)(max. 6 cycles) via i.v. bolus injection.~Toxicity scored at every i.v. drug administration and on day 7, 14 and 21 of the cycle.~Step 3: Expansion cohort of the maximally tolerable dose (n=10) Administration of the maximally tolerable dose of L19-IL2(max. 6 cycles) via i.v. bolus injection.~Toxicity scored at every i.v. drug administration and on day 7, 14 and 21 of the cycle."
MAASTRO clinic, Maastricht
Maastricht Radiation Oncology
OTHER