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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)

Must not have

History of another active malignancy in the previous 3 years prior to study entry

More than 2 prior lines for systemic therapy (Recurrent glioblastoma - Group 3 dose escalation only)

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had any other cancer in the last 3 years.

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I have had more than 2 treatments for my brain cancer.

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I have not received any treatment for glioma before.

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My cancer has spread to the lining of my brain and spinal cord.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Group 1: Frequency of dose limiting toxicities (DLTs)

Group 3: Frequency of dose limiting toxicities (DLTs)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 10Eligibility criteria met