Treatment for recurrent or progressive meningiomas using a new radiolabelled somatostatin antagonist

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of a newly developed radiolabelled somatostatin antagonist, 177Lu-DOTA-JR11, in treating recurrent or progressive meningiomas. The study compares the therapeutic index of this new treatment against a standard somatostatin analogue, 177Lu-DOTATOC, in patients with confirmed meningiomas. Participants will undergo a series of treatments and assessments to determine the efficacy and safety of the new therapy. The trial aims to provide insights into the potential benefits of targeted radionuclide therapy for advanced meningioma patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Informed Consent as documented by signature
* Participants of any gender and of age \> 18 years
* Female participants capable of giving birth (who are not surgically sterilized or are less than 2 years in their menopause) must use a medically accepted contraceptive and must agree to use it during and till 3 months after the treatment. As acceptable contraceptive count sexual abstinence or double contraceptive methods: hormonal contraceptive (oral, transdermal, implants or injections) in combination with barrier methods (spiral, condom, diaphragm)
* Male participants must use medically accepted contraceptive during and till 3 months after treatment
* The participants' Karnofsky Performance Status must be ≥ 60
* The participants must be patients with a histologically or clinically confirmed (MRI + somatostatin receptor imaging) recurrent or progressive meningioma
* There must be no other standard therapeutic alternatives for the participants
* The participants tumour must be measurable according to RECIST v1.1 with a minimal diameter of 1.0 cm.
* The participants must have a confirmed expression of somatostatin receptor (SSTR) on 68Ga- DOTATOC positron emission computed tomography (PET)/CT scan
* Blood parameter criteria are:

  h) Leucocytes ≥ 3\*109/L i) Haemoglobin ≥ 80 g/L j) Thrombocytes ≥ 90\*109/L k) Estimated glomerular filtration rate ≥ 50 ml/min l) Albumin \> 25g/L m) alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP): ≤ 5 times upper standard value n) Bilirubin ≤ 2 times upper standard value

Exclusion Criteria:

* Known intolerance against 177Lu, DOTA, JR11, TOC or against one of the components of 177Lu-DOTA-JR11 or 177Lu-DOTATOC
* Ongoing infection at the screening visit or a serious infection in the past 4 weeks
* Administration of another investigational product in the last 60 days before Visit 1 Day 1
* Prior or planed administration of a therapeutic radio-pharmaceutical during 8 half-lives of the used radio-pharmaceutical's radionuclide, also during the ongoing study
* Any extensive Radiotherapy involving bone marrow over the last 3 months before inclusion to the study
* Chemotherapy in the last 2 months before inclusion
* Pregnant or breastfeeding female patients. A pregnancy test will be performed in all women of child bearing potential.
* Any uncontrolled significant medical, psychiatric or surgical condition (active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus \[HbA1c ≥ 9%\], uncontrolled congestive heart disease, etc.) or laboratory findings that might jeopardize the patient's safety or that would limit compliance with the objectives and assessments of the study. Any mental conditions which prevent the patient from understanding the type, extent and possible consequences of the study and/or an uncooperative attitude from the patient.

Where it's running

• University Hospital Basel, Department of Neurosurgery
  Basel, Canton of Basel-City, Switzerland Recruiting

Study contacts

• Principal investigator: Dominik Cordier, PD Dr. med. — University Hospital, Basel, Switzerland
• Study coordinator: Damian Wild, Prof. Dr. med.
• Email: damian.wild@usb.ch
• Phone: +41 61 328 6683

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.