Actively Recruiting
Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors
Led by Nationwide Children's Hospital · Updated on 2026-04-13
65
Participants Needed
4
Research Sites
571 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \<12 years (Phase I) or 12 to \</=39 years (Phase II) to test its safety and efficacy, respectively. Funding Source - FDA OOPD (grant number FD-R-0532-01)
CONDITIONS
Official Title
Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary high-grade CNS tumor (WHO grade III-IV) or meningioma (any grade) that is recurrent, progressive, or refractory
- Patients with DIPG who have biopsy-proven grade II-IV infiltrating glioma
- Tumors must demonstrate uptake on DOTATATE PET/CT with Krenning score ≥2 confirmed centrally
- Prior standard therapy completed with documented progression or recurrence
- Recovery from acute toxicities of all prior treatments to grade ≤1
- Last dose of myelosuppressive chemotherapy at least 21 days prior (42 days if nitrosourea)
- Last dose of investigational/biologic agent at least 7 days prior; 28 days for monoclonal antibodies
- Last fraction of craniospinal/total body radiation >3 months prior, focal radiation >4 weeks prior
- ≥6 months since allogeneic stem cell transplant without active graft vs. host disease
- ≥3 months since autologous stem cell transplant
- Off all colony-forming growth factors for at least 1 week (2 weeks if long-acting)
- Off long-acting somatostatin analogs for at least 4 weeks and short-acting analogs for at least 24 hours
- Stable neurological deficits for at least 1 week; seizures well controlled
- Karnofsky or Lansky performance score ≥50 within 2 weeks
- Adequate bone marrow, renal, liver, and cardiac function as defined
- Stable or decreasing corticosteroid dose for at least 1 week, max 2.5 mg/m2/day dexamethasone
- Negative pregnancy test for females of childbearing potential within 72 hours prior to first dose
- Agreement to use medically acceptable birth control during treatment and specified months after
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Confirmed bone marrow metastatic disease
- Bulky disease: tumor causing uncal herniation or midline shift, tumor >5 cm in one dimension, or significant mass effect
- Nursing mothers
- History of other malignancies unless prior malignancy in remission ≥5 years
- Significant unrelated systemic illness or organ dysfunction compromising safety
- Type I diabetes
- Receiving other anti-cancer or investigational therapies
- Prior or current treatment with 177Lu-DOTATATE/TOC or 90Y-DOTATATE/TOC
- Prisoners
- Unable or unwilling to comply with follow-up visits or study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Withdrawn
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
3
Nationwide Children's Hospital
Columbus, Ohio, United States, 43235
Actively Recruiting
4
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
Research Team
K
Kelsey H Troyer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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