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New treatment option for High Grade Glioma
Official title Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors
ClinicalTrials.gov ID: NCT05278208
What this study is testing
What is LUTATHERA® (Lutetium Lu 177 dotatate)?
LUTATHERA® (Lutetium Lu 177 dotatate) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for high grade glioma.
Also referred to as Lutathera.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 39
You may be able to join if
- All participants must meet the following inclusion and
You likely can't join if
- . No exceptions will be given. Imaging studies to establish eligibility must be done within three weeks prior to enrollment. All other clinical...
- Screening Criteria 1.1 Diagnosis Patient must have a diagnosis of primary high-grade CNS tumor (any histopathologic diagnosis that is WHO grade...
- Eligibility Criteria
- Phase I Age Patient must be ≥ 4 and \<12 years of age at the time of enrollment. Disease Status: Patients who participate in the how well it works...
- Phase II Age Patient must be 12 to \</=39 years at the time of enrollment.
- Inclusion Criteria 3.1 Uptake on [68Ga]Ga-DOTATATE PET Patients must have uptake on DOTATATE PET/CT in at least one tumor lesion (corresponding to...
See the full eligibility criteria
Who can join
- All participants must meet the following inclusion and
What rules you out
- . No exceptions will be given. Imaging studies to establish eligibility must be done within three weeks prior to enrollment. All other clinical evaluations to establish eligibility (except for [68Ga]Ga-DOTATATE PET)...
- Screening Criteria 1.1 Diagnosis 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...
- Eligibility Criteria
- Phase I Age Patient must be ≥ 4 and \<12 years of age at the time of enrollment. Disease Status: Patients who participate in the how well it works expansion cohort must have bi-dimensionally measurable disease, defined...
- Phase II Age Patient must be 12 to \</=39 years at the time of enrollment.
- Inclusion Criteria 3.1 Uptake on [68Ga]Ga-DOTATATE PET Patients must have uptake on DOTATATE PET/CT in at least one tumor lesion (corresponding to known disease) equivalent to a Krenning score ≥2 (confirmed by central...
- Craniospinal irradiation or total body irradiation or radiation to \> 50% of pelvis \> 3 months prior to enrollment.
- Focal irradiation \> 4 weeks prior to enrollment 3.6 Stem Cell Transplant Patient must be:
- ≥ 6 months since allogeneic stem cell transplant prior to enrollment with no evidence of active graft vs. host disease
- ≥ 3 months since autologous stem cell transplant prior to enrollment 3.7 Growth Factors Patients must be off all colony-forming growth factor(s) for at least 1 week prior to enrollment (e.g. filgrastim, sargramostim or...
- Phase I: Patients must be off thrombopoietin receptor agonists for at least 1 week prior to enrollment (e.g. romiplostim, eltrombopag)
- Phase II: Patients can receive concurrent thrombopoietin receptor agonists 3.9 Somatostatin analogs Patients must be off long-acting somatostatin analogs for at least 4 weeks and off short-acting somastatin analogs...
- Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment, documented by a detailed neurological exam.
- Patients with seizure disorders may be enrolled if seizures are well controlled. 3.11 Performance Status Karnofsky Performance Scale (KPS for \> 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age)...
- Adequate Bone Marrow Function as defined as:
- Absolute neutrophil count ≥ 1.0 x 109 cells/ L
- Platelets ≥100 x 109 cells/ L (unsupported, defined as no platelet transfusion within 7 days)
- Hemoglobin ≥8 g/dl (may receive transfusions)
- Adequate Renal Function as defined as:
- Creatinine clearance or radioisotope GFR \>70mL/min/1.73m2 OR
- A serum creatinine based on (Schwartz et al. J. Peds, 106:522, 1985) age/gender as follows: 1 to \< 2 years: maximum serum creatinine 0.6 mg/dL for males and females. 2 to \< 6 years: maximum serum creatinine 0.8 mg/dL...
- Adequate Liver Function as defined as:
- Total bilirubin ≤ 3 times institutional upper limit of normal (ULN) for age
- AST(SGOT)/ALT(SGPT) ≤ 3 times institutional ULN
- Serum albumin ≥ 2g/dL
- Coagulation parameters: INR \<1.5 times ULN and aPTT \<1.5 times ULN unless patients are receiving therapeutic anticoagulation which affects these parameters
- Adequate Cardiac Function as defined as:
- Ejection fraction of ≥ 55% by echocardiogram
- Serum electrolytes (Sodium, Potassium, Chloride) within institutional limits of normal (patients can be on enteral supplementation) 3.13 Corticosteroids Patients who are receiving dexamethasone must be on a stable or...
- Exclusion Criteria 4.1 Confirmed bone marrow metastatic disease Patients with confirmed metastatic disease to bone marrow are ineligible. 4.2 Presence of bulky disease Patients with bulky disease on imaging as described...
- Tumor with evidence of clinically significant uncal herniation or midline shift.
- Tumor with diameter of \>5cm in one dimension on T2/FLAIR.
- Tumor that in the opinion of the site investigator shows significant mass effect in either the brain or spine. Note that patients with metastatic or multi-focal disease (with exception of bone marrow) are eligible as...
- Patients with a history of any other malignancy, except patients with a secondary brain tumor if the patient's prior malignancy has been in remission for at least 5 years from the end of treatment.
- Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise...
- Patients with type I diabetes. 4.5 Concomitant Medications
- Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.
- Prior or current treatment with 177Lu-DOTATATE/TOC or 90Y-DOTATATE/TOC. 4.6 Prisoners will be excluded from this study. 4.7 Inability to participate: Patients who in the opinion of the investigator are unwilling or...
- Inclusion of Women and Minorities Both males and females of all races and ethnic groups are eligible for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Cincinnati, Ohio, United States; Columbus, Ohio, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.