177Lu-DOTATATE for Recurrent Meningioma: a Randomized Phase II Study

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Novel treatments are urgently needed for meningiomas progressing after local therapies (surgery, radiotherapy). So far, no effective systemic therapies are known in this situation. The LUMEN-1 trial will investigate in a prospective randomized trial the efficacy of the precision medicine theranostic concept of combining diagnostic patient selection using PET-based molecular imaging and target-specific therapeutic intervention using a systemically administered radioligand. The rationale for the LUMEN-1 trial is based on the following: (a) high somatostatin receptor (SSTR) expression in meningiomas, (b) wide-spread availability of clinically established SSTR-PET imaging, (c) proven efficacy of SSTR-targeting radioligand therapy using \[177Lu\]Lu-DOTATATE in another tumor type (neuroendocrine tumors), and (d) promising experiences with \[177Lu\]Lu-DOTATATE therapy in compassionate use applications and retrospective case series and interim results from one ongoing uncontrolled prospective trial in meningiomas. LUMEN-1 is the first randomized clinical trial to investigate \[177Lu\]Lu-DOTATATE therapy in refractory meningioma and may open new avenues for treatment and research in this area.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patient ≥ 18 years of age

• Histologically confirmed diagnosis of meningioma (all grades, 1-3 per WHO CNS5, are eligible)

• WHO performance status 0-2

• Measurable disease (at least 10 x10 mm contrast enhancing lesion) on cranial MRI no more than two weeks prior to randomization

• Radiologically documented progression of any existing tumour (growth \> 25% in the last two years) or appearance of new lesions (including intra- and extracranial manifestations)

• Somatostatin receptor (SSTR)-positive confirmed by PET imaging with scan performed within four weeks before randomization (baseline SSTR-PET is considered as positive when meningioma uptake intensity exceeds a SUVmax of 2.3).

• At least one prior surgery and one line of external beam radiotherapy for meningioma

• Adequate liver, renal and haematological function within four weeks prior to randomization (1) Neutrophils ≥ 1.5 x 109/L, hemoglobin ≥ 9 g/dL or hemoglobin ≥ 5.6 mmol/L, platelets ≥ 100 x 109/L, (2) Total Bilirubin ≤ 1 x ULN, SGPT/ALT and SGOT/AST ≤ 2.5 x ULN, (3) Albumin ≥ 30 g/L, (4) Serum creatinine ≤ 1.5 x ULN, (5) Creatinine clearance \> 40 ml/min as calculated by CKD-EPI 2021

• Participants must have the following electrolyte values within normal limits or corrected to be within normal limits with supplements prior to first dose of study medication: (1) Potassium (potassium level of up to 6.0 mmol/L is acceptable at study entry if associated with creatinine clearance within normal limits calculated using CKD-EPI formula). Mild decrease below lower limit of normal (LLN) is acceptable at study entry if considered not clinically significant by investigator, (2) Magnesium, with the exception of magnesium level \> ULN - 3.0 mg/dL (1.23 mmol/L) associated with creatinine clearance within normal limits calculated using CKD-EPI formula. Mild decrease below LLN is acceptable at study entry if considered not clinically significant by Investigator, (3) Total calcium (corrected for serum albumin) level of up to 12.5 mg/dL (3.1 mmol/L) is acceptable at study entry if associated with creatinine clearance within normal limits calculated using CKD-EPI formula. Mild decrease below LLN is acceptable at study entry if considered not clinically significant by Investigator.

• Patients who are receiving corticosteroid treatment with dexamethasone, must be treated with a dose of ≤4 mg/day (or other corticosteroids equivalent dose) for a minimum of 7 days initiation of study treatment.

• Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to randomization. A positive urine pregnancy test result must immediately be confirmed using a serum test. A pregnancy test is to be reported within 7 days prior to the first dose of the study treatment. Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons.

• Patients of childbearing / reproductive potential should use adequate birth control measures during the study treatment period and for at least 6 months after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Such methods include: (1) Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), (2) Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), (3) Intrauterine device (IUD), (4) Intrauterine hormone-releasing system (IUS), (5) Bilateral tubal occlusion, (6) Vasectomized partner, (7) Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)

• Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 7 months after the last study treatment.

• Before patient 's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.

Locations
Other Locations
Austria
A.O Landeskrankenhaus - Innsbruck Universitaetsklinik
RECRUITING
Innsbruck
Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH unikliniken
RECRUITING
Vienna
France
Centre Leon Berard
RECRUITING
Lyon
Centre Eugene Marquis
RECRUITING
Rennes
CHRU de Nancy - Hopitaux De Brabois
RECRUITING
Vandœuvre-lès-nancy
Gustave Roussy
RECRUITING
Villejuif
Norway
Oslo University Hospital - Radiumhospitalet
RECRUITING
Oslo
St Olavs University Hospital - St. Olavs Hospital, Trondheim University Hospital
RECRUITING
Trondheim
Spain
Vall D Hebron - Hospital Universitari Vall d'Hebron -Vall d'Hebron Institut Oncologia
RECRUITING
Barcelona
Hospital Universitario 12 De Octubre
RECRUITING
Madrid
Switzerland
Oncology Institute of Southern Switzerland (IOSI) - Ospedale San Giovanni
NOT_YET_RECRUITING
Bellinzona
UniversitaetsSpital Zurich - Neurology Clinic
NOT_YET_RECRUITING
Zurich
Contact Information
Primary
EORTC
eortc@eortc.org
+32 2 774 16 11
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2028-12-22
Participants
Target number of participants: 136
Treatments
Active_comparator: Control group: local standard of care (LOC)
According to local standard practice, treatment in the control arm is left to the investigator's discretion.~* Hydroxyurea~* Bevacizumab~* Sunitinib~* Octreotide (Sandostatin LAR)~* Everolimus~* No treatment (observation with regular follow-up and best supportive care)
Experimental: Experimental group: 177Lu-DOTATATE
Patients will receive 177Lu-DOTATATE with a total dose of 7.4 GBq/cycle every four (4) weeks for four (4) cycles as an IV infusion
Related Therapeutic Areas
Sponsors
Leads: European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: Novartis

This content was sourced from clinicaltrials.gov

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