A Dose Finding Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Standard of Care and in Recurrent Glioblastoma as a Single Agent.

PHASE1RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 10, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

February 25, 2026

Conditions
Glioblastoma
Interventions
DRUG

[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."

DRUG

[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)

OTHER

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)"

OTHER

Radiotherapy

2 Gy/day, 5 days per week followed by 2 days of rest, for 6 consecutive weeks

Trial Locations (15)

1011

ACTIVE_NOT_RECRUITING

Novartis Investigative Site, Lausanne

8091

RECRUITING

Novartis Investigative Site, Zurich

10032

RECRUITING

Col Uni Med Center New York Presby, New York

13885

COMPLETED

Novartis Investigative Site, Marseille

15213

ACTIVE_NOT_RECRUITING

University of Pittsburgh, Pittsburgh

18014

COMPLETED

Novartis Investigative Site, Granada

28041

ACTIVE_NOT_RECRUITING

Novartis Investigative Site, Madrid

28050

ACTIVE_NOT_RECRUITING

Novartis Investigative Site, Madrid

69677

RECRUITING

Novartis Investigative Site, Bron

77030

RECRUITING

MD Anderson Cancer Center Uni of Te, Houston

02215

RECRUITING

Dana Farber Cancer Institute, Boston

53792-1615

RECRUITING

University of Wisconsin School of Medicine and Public Health, Madison

4200-072

RECRUITING

Novartis Investigative Site, Porto

08035

COMPLETED

Novartis Investigative Site, Barcelona

08036

ACTIVE_NOT_RECRUITING

Novartis Investigative Site, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY