ACTIVE_NOT_RECRUITING

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 GBM Radioligand Therapy RLT [177Lu]Lu-DOTA-TATE Temozolomide O-6-methylguanine-DNA methyltransferase MGMT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2022-05-10

Study Completion:2027-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05109728

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.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals

STUDY_DIRECTOR

Novartis Pharmaceuticals

Study Locations (Sites)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Col Uni Med Center New York Presby

New York, New York, 10032

United States

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213

United States

MD Anderson Cancer Center Uni of Te

Houston, Texas, 77030

United States

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792-1615

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-10

Study Completion Date2027-07-31

Study Record Updates

Study Start Date2022-05-10

Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

Glioblastoma
GBM
Radioligand Therapy
RLT
[177Lu]Lu-DOTA-TATE
Temozolomide
O-6-methylguanine-DNA methyltransferase
MGMT

Additional Relevant MeSH Terms

Glioblastoma