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Radioisotope Therapy

Lutathera for Brain Tumor

Phase 1 & 2

Recruiting

Led By Margot Lazow

Research Sponsored by Ralph NULL Salloum

Eligibility Criteria Checklist

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

Must have

Patients must have had their last fraction of craniospinal irradiation or total body irradiation or radiation to > 50% of pelvis > 3 months prior to enrollment, and focal irradiation > 4 weeks prior to enrollment

Patient must have a diagnosis of primary high-grade CNS tumor (any histopathologic diagnosis that is WHO grade III-IV) or meningioma (any histologic grade) that is recurrent, progressive, or refractory

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 months

Awards & highlights

Study Summary

This trial will test the safety and efficacy of Lutathera, a new drug for treating brain tumors, in children and young adults. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months.

Who is the study for?

This trial is for children and young adults with high-grade brain tumors or meningiomas that have gotten worse or come back after treatment. They must be stable neurologically, not on certain cancer drugs, and their tumors should show a specific protein (SST2A) and take up a special dye on PET scans. Ages 4-12 are in Phase I, while those older than 12 are in Phase II.Check my eligibility

What is being tested?

The study tests Lutathera (177Lu-DOTATATE), given through the vein every 8 weeks for up to four doses over eight months. It aims to see if it's safe and works well against these brain tumors/meningiomas that absorb a particular diagnostic dye indicating they may respond to this therapy.See study design

What are the potential side effects?

Possible side effects of Lutathera include nausea, vomiting, fatigue, low blood counts leading to increased infection risk or bleeding problems, liver and kidney issues, hormonal imbalances due to pituitary damage, and rarely allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I had major radiation therapy more than 3 months ago, or targeted radiation over 4 weeks ago.

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I have a high-grade brain tumor or meningioma that is not responding to treatment.

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I received my last cancer treatment affecting my bone marrow 21 days ago, or 42 days ago if it was a specific type called nitrosourea.

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My tumor shows significant activity on a specific PET/CT scan.

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I have enough tumor samples for testing before the trial starts.

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My cancer has returned or worsened after standard treatment.

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My tumor shows SST2A expression.

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I am either 4-11 years old for Phase I or 12+ years old for Phase II.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Assess PFS of Lutathera in CNS patients >12 years

Calculate the incidence of treatment related adverse events as assessed by CTCAE v5.0 in pediatric (4-12 yo) CNS patients treated with Lutathera

Estimate MTD of Lutathera in pediatric CNS patients 4-12 years

+1 more

Secondary outcome measures

Calculate the incidence of treatment related adverse events as assessed by CTCAE v5.0 in CNS patients older than 12 yrs treated with Lutathera

Objective Response Rate of Lutathera in CNS patients >12 years

Other outcome measures

Anti-tumor activity of Lutathera

Correlation of SST2A expression with clinical and molecular features in high-grade CNS tumor patients treated with Lutathera

Prevalence of SST2A expression in patients with different high-grade CNS tumors

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase I-IIExperimental Treatment1 Intervention

Pediatric patients (4 -12 years, Phase I) and adolescent and young adult patients (>12years, Phase II) with recurrent/progressive high-grade central nervous system tumors and meningiomas that express SST2A and demonstrate uptake on DOTATATE PET will receive Lutathera once every 8 weeks (1 cycle) for a total of 4 doses over 8 months Phase I starting dose will be 200 mCi*(BSA/1.73m2), corresponding to the BSA-adjusted FDA approved adult Lutathera dosing. The first cycle will be used as the DLT period. Once MTD/RP2D is established, an efficacy expansion cohort of up to 10 patients will be opened to determine the preliminary efficacy of MTD/RP2D of Lutathera in this cohort Phase II patients will receive the adult RP2D of 200 mCi every 8 weeks to determine the anti-tumor activity of Lutathera in this patient population, through evaluation of 6-month PFS as the primary efficacy endpoint. Response will be assessed on imaging (brain/spine MRI and DOTATATE PET) following every cycle.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ralph NULL SalloumLead Sponsor

Ralph SalloumLead Sponsor

Children's Hospital Medical Center, CincinnatiOTHER

815 Previous Clinical Trials

6,531,526 Total Patients Enrolled

Media Library

Lutathera (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05278208 — Phase 1 & 2

Brain Tumor Research Study Groups: Phase I-II

Brain Tumor Clinical Trial 2023: Lutathera Highlights & Side Effects. Trial Name: NCT05278208 — Phase 1 & 2

Lutathera (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05278208 — Phase 1 & 2

Frequently Asked Questions

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

Does this research endeavor currently have any open enrollment opportunities?

"Clinicaltrials.gov has revealed that this study, which was initially published on September 25th 2022 and revised lastly on the twelfth of September, is no longer recruiting participants. Although there are still 3674 other trials enrolling candidates at present."

Answered by AI

How many healthcare facilities are undertaking this investigation?

"9 clinical trial centres are available, including the Children's Hospital of Philadelphia in Philadelphia, Texas Children's Hospital located in Houston, and Ann & Robert H. Lurie Children's Hosptial of Chicago situated in Chicago. Additionally there is a selection other sites offering this study."

Answered by AI

Who else is applying?

What state do they live in?

Puerto Rico

What site did they apply to?

Duke University Health System

Texas Children's Hospital

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

My son was diagnosed on 9/14 with a recurrent anaplastic ependymoma after 3.5 years NED. The care team is not recommending surgery so we are exploring all other relevant options.

PatientReceived 2+ prior treatments