60
Participants
Start Date
May 10, 2022
Primary Completion Date
December 31, 2025
Study Completion Date
February 25, 2026
[177Lu]Lu-DOTA-TATE
"Group 1: \[177Lu\]Lu-DOTA-TATE, dose level 0 (150mCi) administered every 4 weeks. Three provisional dose levels (Dose level +2: 250 mCi; Dose level +1: 200 mCi; Dose level -1: 100 mCi) will be assessed.~Group 3: \[177Lu\]Lu-DOTA-TATE, dose level 0 (150mCi) administered every 3 weeks. Three provisional dose levels (Dose level +2: 250 mCi; Dose level +1: 200 mCi; Dose level -1: 100 mCi) will be assessed."
[68Ga]Ga-DOTA-TATE
2 MBq/kg of body weight (0.054 mCi/kg), with a minimum dose of 100 MBq (2.7 mCi) and maximum dose of 200 MBq (5.4 mCi)
Temozolomide
"Concomitant Phase: Temozolomide 75mg/m2/d p.o until last day of EBRT.~Maintenance Phase: Temozolomide p.o 150 mg/m2/d during cycle 1 then 200 mg/m2/d for the following cycles if tolerated well in Cycle 1. 6 cycles total (1 cycle = every 28 days)"
Radiotherapy
2 Gy/day, 5 days per week followed by 2 days of rest, for 6 consecutive weeks
ACTIVE_NOT_RECRUITING
Novartis Investigative Site, Lausanne
RECRUITING
Novartis Investigative Site, Zurich
RECRUITING
Col Uni Med Center New York Presby, New York
COMPLETED
Novartis Investigative Site, Marseille
ACTIVE_NOT_RECRUITING
University of Pittsburgh, Pittsburgh
COMPLETED
Novartis Investigative Site, Granada
ACTIVE_NOT_RECRUITING
Novartis Investigative Site, Madrid
ACTIVE_NOT_RECRUITING
Novartis Investigative Site, Madrid
RECRUITING
Novartis Investigative Site, Bron
RECRUITING
MD Anderson Cancer Center Uni of Te, Houston
RECRUITING
Dana Farber Cancer Institute, Boston
RECRUITING
University of Wisconsin School of Medicine and Public Health, Madison
RECRUITING
Novartis Investigative Site, Porto
COMPLETED
Novartis Investigative Site, Barcelona
ACTIVE_NOT_RECRUITING
Novartis Investigative Site, Barcelona
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY