Lutathera for Progressive Meningioma
Recruiting in Palo Alto (17 mi)
Overseen byKenneth W Merrell
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Mayo Clinic
Must not be taking: Antiretrovirals, Octreotide
Disqualifiers: Pregnancy, HIV, Uncontrolled illness, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial studies how well Lutathera works in treating patients with meningioma that cannot be treated with surgery and is getting worse after radiation therapy. Lutathera is a radioactive drug that targets and kills tumor cells. The goal is to see if it is safe and effective for these patients.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on somatostatin LAR or short-acting octreotide, you may need to stop these before treatment. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Lutathera for progressive meningioma?
Research shows that Lutathera (Lutetium Lu 177 Dotatate) can help stabilize tumor growth in some patients with progressive meningioma, especially those with certain types of tumors that have specific receptors (somatostatin receptors). In one study, 85.7% of patients with a certain type of meningioma (WHO grade II) did not see their tumors grow for at least six months after treatment.
12345Is Lutathera safe for treating meningioma?
Lutathera (Lutetium Lu 177 Dotatate) has been used safely in patients with meningiomas and other tumors, with studies showing it is generally well tolerated without notable adverse events. Radiation safety measures are important during treatment to minimize exposure, but it can be safely administered in a hospital setting.
12467How does the drug Lutathera differ from other treatments for progressive meningioma?
Lutathera is unique because it uses a radioactive substance, Lutetium Lu 177, to target and destroy cancer cells, which is different from traditional treatments like surgery or chemotherapy that do not use radioactivity. This approach is novel for progressive meningioma, as there are no standard treatments specifically for this condition.
89101112Eligibility Criteria
This trial is for adults with inoperable, progressive meningioma after radiation therapy. They must have had prior treatments like surgery if possible, show tumor growth on scans, and not be candidates for more radiotherapy. Participants need to have a certain level of physical fitness (ECOG PS <=2), adequate organ function, and agree to use contraception if applicable.Inclusion Criteria
Your hemoglobin level should be at least 9.0 grams per deciliter.
You have a disease that can be measured or seen by the doctor.
I agree to a 68Ga-DOTATATE PET scan and my scan shows a Krenning score of 2 or higher.
+15 more
Exclusion Criteria
I am not on any experimental drugs for my cancer.
I have a tumor in the covering of my optic nerve or outside my brain.
I am of childbearing age and do not plan to use birth control.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive lutetium Lu 177 dotatate IV over 30-40 minutes every 8 weeks for up to 4 cycles
32 weeks
4 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 5 years
Every 3 months for 2 years, then every 6 months
Participant Groups
The trial tests Lutathera's effectiveness and safety in treating meningiomas that worsen post-radiation. It involves radioactive drug infusion targeting cancer cells, alongside assessments through questionnaires, quality-of-life measures, MRI scans, and PET imaging using Gallium Ga 68-DOTATATE.
1Treatment groups
Experimental Treatment
Group I: Treatment (gallium Ga 68-DOTATATE PET/MRI, Lutathera)Experimental Treatment8 Interventions
Patients receive gallium Ga 68-DOTATATE IV and undergo a PET/MRI or PET/CT before cycles 1 and 4. Patients then receive lutetium Lu 177 dotatate IV over 30-40 minutes. Treatment repeats every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI on study and during follow-up, as well as blood sample collection and possible SEPCT/CT dosimetry on study.
Lutetium Lu 177 Dotatate is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Lutathera for:
- Gastroenteropancreatic neuroendocrine tumors
🇺🇸 Approved in United States as Lutathera for:
- Gastroenteropancreatic neuroendocrine tumors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Efficacy of 177Lu-Dotatate Therapy in the Treatment of Recurrent Meningioma. [2022]A 62-year-old man presented with a history of atypical meningioma (World Health Organization grade II) and recurrent as anaplastic meningioma (World Health Organization grade III). His previous treatments included multiple surgical resections, fractionated radiation therapy, stereotactic radiosurgery, everolimus/octreotide long-acting release, bevacizumab, and hydroxyurea. Magnetic resonance imaging revealed rapid volumetric progression over the prior 9 months, with a near tripling in size from 29.9 cm3 to 80.4 cm3. Indium In 111 octreotide scanning confirmed the presence of somatostatin receptors within the tumor. Lutetium Lu 177 dotatate was administered intravenously at a dose of 200 mCi per dose every 8 weeks for 4 cycles. Treatment was tolerated very well, with no notable adverse events. Tumor volume initially increased to 98.3 cm3 after cycle 1 of treatment and subsequently decreased to 91.2 cm3 after cycle 2. Eight months after treatment onset, the tumor volume remained stable (93.4 cm3).
Somatostatin Receptor Theranostics for Refractory Meningiomas. [2022]Somatostatin receptor (SSTR)-targeted peptide receptor radionuclide therapy (PRRT) represents a promising approach for treatment-refractory meningiomas progressing after surgery and radiotherapy. The aim of this study was to provide outcomes of patients harboring refractory meningiomas treated by 177Lu-DOTATATE and an overall analysis of progression-free survival at 6 months (PFS-6) of the same relevant studies in the literature. Eight patients with recurrent and progressive WHO grade II meningiomas were treated after multimodal pretreatment with 177Lu-DOTATATE between 2019 and 2022. Primary and secondarily endpoints were progression-free survival at 6-months (PFS-6) and toxicity, respectively. PFS-6 analysis of our case series was compared with other similar relevant studies that included 86 patients treated with either 177Lu-DOTATATE or 90Y-DOTATOC. Our retrospective study showed a PFS-6 of 85.7% for WHO grade II progressive refractory meningiomas. Treatment was clinically and biologically well tolerated. The overall analysis of the previous relevant studies showed a PFS-6 of 89.7% for WHO grade I meningiomas (n = 29); 57.1% for WHO grade II (n = 21); and 0 % for WHO grade III (n = 12). For all grades (n = 86), including unknown grades, PFS-6 was 58.1%. SSTR-targeted PRRT allowed us to achieve prolonged PFS-6 in patients with WHO grade I and II progressive refractory meningiomas, except the most aggressive WHO grade II tumors. Large scale randomized trials are warranted for the better integration of PRRT in the treatment of refractory meningioma into clinical practice guidelines.
Evaluation of the SSTR2-targeted radiopharmaceutical 177Lu-DOTATATE and SSTR2-specific 68Ga-DOTATATE PET as imaging biomarker in patients with intracranial meningioma. [2023]There are no effective medical therapies for patients with meningioma who progress beyond surgical and radiotherapeutic interventions. Somatostatin receptor Type 2 (SSTR2) represents a promising treatment target in meningiomas. In this multicenter, single-arm phase II clinical study (NCT03971461), the SSTR2-targeting radiopharmaceutical 177Lu-DOTATATE is evaluated for its feasibility, safety, and therapeutic efficacy in these patients.
In Vivo Measurement and Characterization of a Novel Formulation of [177Lu]-DOTA-Octreotate. [2020]Label="OBJECTIVES" NlmCategory="OBJECTIVE">Lutetium-177 can be made with high specific activity and with no other isotopes of lutetium present, referred to as "No Carrier Added" (NCA) 177Lu. We have radiolabelled DOTA-conjugated peptide DOTA-(Tyr3)-octreotate with NCA 177Lu ("NCA-LuTATE") and used it in nearly 40 therapeutic administrations for subjects with neuroendocrine tumours or meningiomas. In this paper, we report on our initial studies on aspects of the biodistribution and dosimetry of NCA-LuTATE from gamma camera 2D whole body (WB) and quantitative 3D SPECT (qSPECT) 177Lu imaging.
Response assessment of somatostatin receptor targeted radioligand therapies for progressive intracranial meningioma. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND"> In somatostatin receptor (SSTR) expressing progressive meningioma, peptide receptor radionuclide therapy (PRRT) has shown effect in small clinical series. However, standardized treatment and response assessment protocols are lacking. We present our experience on PPRT with 177Lu-DOTATATE in progressive meningioma with a special emphasis on state-of-the-art response assessment.
Radiation Safety Observations Associated with 177Lu Dotatate Patients. [2020]Lutetium-177 dotatate, marketed under the name Lutathera®, is proving to be a valuable tool for physicians treating patients with neuroendocrine somatostatin-receptive tumors. Treatment consists of four cycles of 7.4 GBq of Lu dotatate infused intravenously over 30 to 40 minutes. This paper focuses on the radiation safety implications of patients undergoing Lu dotatate treatments at two large medical centers in the United States under the manufacturer's Expanded Access Protocol. Radiation safety precautions are described for the treatment of patients to control for radiation exposure and potential contamination. Ideally, the room used for administration should have a toilet, or one that is in close proximity, and covering should be provided to minimize contamination and clean up. The patient will meet the requirements in 10 CFR Part 35.75 for immediate release based on administered activity or measured exposure rate, but will need to be provided with written instruction on how to keep doses to other individuals ALARA. Disposal of the radioactive waste from Lu dotatate therapy can present some hazard control issues due to the long-lived Lu contaminant.Based on our experience, Lu dotatate therapy is an effective outpatient procedure that can safely occur in any hospital procedural room without the need for additional local shielding. Administration can be accomplished safely with attention paid to the administration set-up and proper administration procedures. Exposure to staff or to adjacent areas is minimal.
Gallium-68 DOTATATE PET in the Evaluation of Intracranial Meningiomas. [2020]Meningiomas are the most common primary intracranial tumors, typically treated with surgery and adjuvant radiation in cases of subtotal resection and/or higher histopathologic grade. Contrast-enhanced magnetic resonance imaging (MRI) is the gold standard for postoperative assessment and adjuvant treatment planning. However, MRI can have limited accuracy particularly in the presence of posttreatment change. [68Ga]-DOTATATE is a Positron Emission Tomography (PET) radiotracer targeting somatostatin receptor 2A (SSTR2A). SSTR2A is a reliable biomarker of meningiomas. We report a consecutive case series of 20 patients evaluated with [68Ga]-DOTATATE PET/MRI, propose a novel approach to quantitative analysis, and discuss clinical implications.
Precocious puberty associated with neurofibromatosis and optic gliomas. Treatment with luteinizing hormone releasing hormone analogue. [2019]Seven children with central precocious puberty and either neurofibromatosis and/or optic gliomas were referred to the National Institutes of Health, Bethesda, Md, for evaluation and treatment with the long-acting luteinizing hormone releasing hormone analogue (LHRHa) D-Trp6-Pro9-NEt-LHRH. Only six of the seven children chose to receive treatment. Four children presented with neurofibromatosis, three of whom also had optic gliomas; the remaining three children had isolated optic gliomas, without other neurocutaneous stigmas. All had central precocious puberty mediated by activation of the hypothalamic-pituitary-gonadal axis. Six months of LHRHa therapy caused suppression of gonadotropin and sex steroid levels, stabilization or regression of secondary sexual characteristics, and decreases in growth velocity and the rate of bone age maturation. We conclude that LHRHa therapy is effective in the treatment of central precocious puberty secondary to neurofibromatosis and/or optic gliomas.
Radiation therapy of optico-hypothalamic gliomas (OHG)--radiographic response, vision and late toxicity. [2019]Management strategies for optic pathway gliomas include observation, surgery, irradiation, chemotherapy and a combination of these modalities. It has been the policy of our University Hospital to consider radiation as the standard treatment for progressive optic pathway gliomas. This report describes the clinical presentation, treatment patterns and outcome with special emphasis on the long term functional status of patients with optico-hypothalamic gliomas (OHG).
Treatment of optic pathway hypothalamic gliomas in childhood: experience with 18 consecutive cases. [2011]The aim of this study was to present our 17-year experience (1989 to 2006) in the treatment of optic pathway/hypothalamic gliomas (OPHG) in 18 children younger than 17 years (median age, 66 mo). Only 2 of these had evidence of neurofibromatosis-1. OPHG was diagnosed using computed tomography and/or magnetic resonance imaging. Histologic studies showed low-grade astrocytoma (WHO grade I or II) in 16 cases, anaplastic astrocytoma in 1, and oligoastrocytoma (WHO grade III) in 1. Treatment included partial tumor resection in 12 patients, chemotherapy in 5, and radiotherapy in 3. Ophthalmologic and visual alterations occurred in 12 patients, endocrine alterations in 6, and neurologic signs in 5. All treatment modalities led to tumor shrinkage and stabilization for a variable period, but none of them totally eradicated the tumor. Fourteen (78%) of 18 patients had a sustained reduction of tumor size between 6 months and 17 years. The 5-year overall and progression-free survival rates were 80.0% and 63.3%, respectively. Fifty-six percent of patients had endocrinologic sequelae, with growth hormone deficiency being the most common. Two patients died, none with neurofibromatosis-1, with a hypothalamic/chiasmatic tumor with suprasellar extension and accompanying electrolyte abnormalities. Because progression of these tumors is slow and associated with endocrinopathy, we recommend chemotherapy as a primary treatment of OPHG if the disease progresses.
Radiation Therapy for Optic Pathway and Hypothalamic Low-Grade Gliomas in Children. [2018]The long-term survival of pediatric patients with optic pathway or hypothalamic low-grade glioma (LGG) who receive radiation therapy (RT) has not been previously assessed.
Definitive radiation therapy in the management of symptomatic patients with optic glioma. Survival and long-term effects. [2019]We reviewed 24 children who had symptomatic gliomas that involved the optic chiasm and were treated with definitive radiation therapy from 1971 to 1986. In eight patients (33%), histologic confirmation of low-grade astrocytoma was obtained. Patients had radiation therapy only if there was evidence of visual deterioration or other clinical or radiographic evidence of disease progression. Radiation doses ranged from 4500 to 5660 cGy (median, 5400 cGy) with up to a 17-year follow-up period (median, 6 years). The 6-year actuarial freedom from disease progression and overall 6-year survival are 88% and 100%, respectively. Visual improvement or stabilization was seen in 21 (91%) patients after radiation. A high incidence of endocrine abnormalities is reported, with 15 of the 18 patients evaluated after treatment showing growth hormone deficiency. We conclude that definitive radiation therapy is associated with tumor control in most of the patients with progressive optic chiasm gliomas. However, neuropsychiatric and endocrine abnormalities are significant problems that need additional evaluation in these children.