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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
Must not have
Patients with any clinically significant unrelated systemic illness, serious infections, or significant cardiac, pulmonary, hepatic or other organ dysfunction
Patients who are receiving any other anti-cancer or investigational drug therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests Lutathera, a radioactive drug given through an IV, in patients with certain brain tumors that haven't responded to other treatments. The drug attaches to cancer cells and uses radiation to kill them.
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.
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.
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 belowSelect...
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.
Select...
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.
Select...
I have enough tumor samples for testing before the trial starts.
Select...
My cancer has returned or worsened after standard treatment.
Select...
My tumor shows SST2A expression.
Select...
I am either 4-11 years old for Phase I or 12+ years old for Phase II.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any serious illnesses or organ problems.
Select...
I am not currently on any cancer treatment or experimental drugs.
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I have been treated with 177Lu-DOTATATE/TOC or 90Y-DOTATATE/TOC.
Select...
My cancer has spread to my bone marrow.
Select...
I have a history of cancer.
Select...
I have had a condition where my lymphocytes grow abnormally.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
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 study objectives
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Lutathera (177Lu-DOTATATE) works by targeting somatostatin receptors, which are often overexpressed in certain types of brain tumors, including high-grade CNS tumors and meningiomas. The drug binds to these receptors and delivers targeted radiation directly to the tumor cells, minimizing damage to surrounding healthy tissue.
This targeted approach is crucial for brain tumor patients as it helps to reduce the side effects typically associated with conventional radiation therapy, thereby preserving neurological function and improving quality of life. Other common treatments for brain tumors, such as temozolomide and bevacizumab, work through different mechanisms like DNA damage and inhibition of blood vessel growth, respectively, but they also aim to maximize tumor control while minimizing harm to normal brain tissue.
Find a Location
Who is running the clinical trial?
Ralph NULL SalloumLead Sponsor
Nationwide Children's HospitalLead Sponsor
348 Previous Clinical Trials
5,228,467 Total Patients Enrolled
Ralph SalloumLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have type I diabetes.I had major radiation therapy more than 3 months ago, or targeted radiation over 4 weeks ago.I do not have any serious illnesses or organ problems.Patients with large tumors as seen on imaging.I haven't had any cancer, except for skin cancer, in the last 5 years.I have a high-grade brain tumor or meningioma that is not responding to treatment.I am not currently on any cancer treatment or experimental drugs.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.My tumor shows significant activity on a specific PET/CT scan.My neurological symptoms have been stable for at least a week.I have enough tumor samples for testing before the trial starts.I have taken a pregnancy test in the last 72 hours and it was negative.I have been treated with 177Lu-DOTATATE/TOC or 90Y-DOTATATE/TOC.I understand the study and agree to sign the consent form.My cancer has spread to my bone marrow.My cancer has returned or worsened after standard treatment.It's been over 6 months since my allogeneic transplant or 3 months since my autologous transplant, with no active graft vs. host disease.Women who are currently breastfeedingI haven't taken any growth factors or somatostatin analogs recently.I have recovered from side effects of my last cancer treatment, which was over a week ago.I can do most activities but may need help, regardless of my age.I have been on a stable or decreasing dose of dexamethasone, not exceeding 2.5mg/m2/day, for at least a week.My tumor shows SST2A expression.My neurological condition has been stable for at least a week.I have a history of cancer.I am either 4-11 years old for Phase I or 12+ years old for Phase II.I haven't taken long-acting somatostatin analogs for 4 weeks or short-acting ones for 24 hours.I have had a condition where my lymphocytes grow abnormally.You do not live in the United States.My previous cancer has been in remission for over 5 years.I have recovered from side effects of my previous cancer treatments.My organs and bone marrow are working well.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I-II
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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