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Radioisotope Therapy

Lu-DOTA-TATE + Standard Therapy for Glioblastoma

Phase 1

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is >= 18 years on the day of signing informed consent form

Presence of Gadolinium enhancing tumor in pre-surgery magnetic resonance imaging (MRI) (Newly diagnosed glioblastoma - Group 1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2 years (estimated final os analysis) from date of first study treatment

Awards & highlights

Study Summary

This trial will investigate the safety & efficacy of two new treatments for Glioblastoma, & establish the recommended dose for three different patient groups.

Who is the study for?

This trial is for adults over 18 with confirmed glioblastoma, a type of brain cancer. They must have good bone marrow and organ function, and normal electrolyte levels. It's not open to those getting other active treatments for glioblastoma, with widespread leptomeningeal disease or another active cancer in the last 3 years.Check my eligibility

What is being tested?

[177Lu]Lu-DOTA-TATE is being tested both as an add-on to standard care (radiotherapy and Temozolomide) for new glioblastoma patients and alone in those whose glioblastoma has come back. The study aims to find the right dose of [177Lu]Lu-DOTA-TATE.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, kidney damage, and temporary or permanent infertility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My MRI shows a gadolinium-enhancing tumor.

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My diagnosis is glioblastoma.

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My glioblastoma has returned once or twice after treatment, including radiation.

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My glioblastoma has returned after initial treatment including radiation.

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My brain tumor has grown despite treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years (estimated final os analysis) from date of first study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2 years (estimated final os analysis) from date of first study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years (estimated final os analysis) from date of first study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Group 1: Frequency of dose limiting toxicities (DLTs)

Group 3: Frequency of dose limiting toxicities (DLTs)

Secondary outcome measures

Group 1: Absorbed radiation doses of [177Lu]Lu-DOTA-TATE

Group 1: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) of [177Lu]Lu-DOTA-TATE

Group 1: Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of [177Lu]Lu-DOTA-TATE

+25 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 3 - Recurrent GBExperimental Treatment2 Interventions

Participants with recurrent glioblastoma will receive [177Lu]Lu-DOTA-TATE as single agent therapy every 3 weeks +/- 2 days

Group II: Group 1 - Newly diagnosed GBExperimental Treatment4 Interventions

Participants with newly diagnosed glioblastoma will receive [177Lu]Lu-DOTA-TATE every 4 weeks +/- 2 days, starting 7 to 10 days prior to initiation of Radiotherapy (RT) and Temozolomide (TMZ)

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,198,249 Total Patients Enrolled

23 Trials studying Glioblastoma

1,632 Patients Enrolled for Glioblastoma

Media Library

[177Lu]Lu-DOTA-TATE (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05109728 — Phase 1

Glioblastoma Research Study Groups: Group 1 - Newly diagnosed GB, Group 3 - Recurrent GB

Glioblastoma Clinical Trial 2023: [177Lu]Lu-DOTA-TATE Highlights & Side Effects. Trial Name: NCT05109728 — Phase 1

[177Lu]Lu-DOTA-TATE (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05109728 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the potential risk posed by Group 3 - Recurrent GB to individuals?

"Due to the limited amount of clinical evidence supporting safety and efficacy, our team at Power has assigned a score of 1 in regards to Group 3 - Recurrent GB's security."

Answered by AI

Has the recruitment of participants for this research commenced?

"Clinicaltrials.gov data confirms that this research endeavour, which commenced on May 10th 2022, is actively canvasing for patients to join the study. The trial was most recently amended on June 19 2023."

Answered by AI

How many healthcare centers are executing this experiment?

"This trial is currently being conducted in 9 locations, including Lausanne, Madrid and Zurich. To keep travel commitments to a minimum, it is best that you choose the site closest to your current address if accepted into this study."

Answered by AI

Have any other investigations been conducted concerning Group 3 - Recurrent GB?

"Currently, 32 medical trials pertaining to Group 3 - Recurrent GB are ongoing with one being in the Phase 3 stage. Although most of these studies can be found in Bethesda, Maryland there is a total of 189 locations offering clinical trials for this particular group."

Answered by AI

How many individuals have currently enrolled in this experiment?

"Affirmative. The data hosted on clinicaltrials.gov illustrates that this medical research, which was originally posted May 10th 2022, is actively seeking participants. A total of 60 people will be welcomed to the trial from 9 different study sites."

Answered by AI

What is the primary aim of this clinical experiment?

"The primary metric of this 42 day clinical trial, as measured from initial administration of [177Lu]Lu-DOTA-TATE, will be the Frequency of Dose Limiting Toxicities (DLTs). Secondary metrics include Time Activity Curves (TACs) which track percentage (%) injected activity versus time in blood, organs and tumor lesions; Modified Response Assessment In Neuro-Oncology Criteria's Overall Objective Status that combines radiographic responses on target lesion, new diseases neurological status and steroid use; and overall survival."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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.

2022. "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.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05109728.

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