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.

Description

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

Conditions

Glioblastoma

Study Overview

Study Details

Study overview

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

A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Radiotherapy With or Without Temozolomide and in Recurrent Glioblastoma as Single Agent

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.

Condition
Glioblastoma
Intervention / Treatment

-

Contacts and Locations

Boston

Dana Farber Cancer Institute Main Site, Boston, Massachusetts, United States, 02215

Pittsburgh

University of Pittsburgh University of Pittsburgh 2, Pittsburgh, Pennsylvania, United States, 15213

Houston

MD Anderson Cancer Center Uni of Te MDACC, Houston, Texas, United States, 77030

Madison

University of Wisconsin School of Medicine and Public Health ., Madison, Wisconsin, United States, 53792-1615

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant is \>= 18 years on the day of signing informed consent form
  • * Histologically confirmed glioblastoma
  • * Adequate bone marrow, organ function and electrolyte values
  • * Presence of Gadolinium enhancing tumor in pre-surgery magnetic resonance imaging (MRI)
  • * Karnofsky Performance Score (KPS) \>= 70 %
  • * Evidence of recurrent disease demonstrated by disease progression using modified Response Assessment in Neuro-Oncology (mRANO) criteria
  • * KPS \>= 60 %
  • * \[68Ga\]Ga-DOTA-TATE uptake by positron emission tomography/computed tomography (PET/CT) or PET/MRI at the tumor region
  • * Presence of Gadolinium enhancement in the tumor region in MRI at the time of diagnosis of tumor recurrence
  • * A second surgery for glioblastoma is allowed provided that the following criteria are met:
  • 1. Residual and measurable disease post-surgery is not required but surgery must have confirmed the diagnosis of recurrence
  • 2. Surgery completed at least 2 weeks prior to study treatment initiation, with post-surgery recovery without any complications related to surgical procedure
  • * Patients experiencing first recurrence of their glioblastoma, after standard or experimental therapy that includes prior EBRT
  • * Participant is receiving additional, concurrent, active therapy for glioblastoma outside of the trial
  • * Extensive leptomeningeal disease
  • * History of another active malignancy in the previous 3 years prior to study entry
  • * Prior administration of a radiopharmaceutical unless 10 or more effective half-lives have elapsed before injection of \[68Ga\]Ga-DOTA-TATE or \[177Lu\]Lu-DOTA-TATE
  • * Early disease progression prior to 3 months from the completion of radiotherapy
  • * Previous treatment with bevacizumab for the treatment of glioblastoma with therapeutic intent, or with bevacizumab as supportive therapy (e.g. edema reduction) within 60 days of initiation of study treatment

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2026-08-10