Treatment for recurrent or progressive meningiomas using a new radiolabelled somatostatin antagonist
Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-Satoreotide (PROMENADE-Study)
This study is testing a new treatment using a special type of radiation to see if it can help people with recurring or worsening meningiomas feel better compared to a standard treatment.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Basel, Canton of Basel-City) |
| Trial ID | NCT04997317 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with histologically or clinically confirmed recurrent or progressive meningiomas who have no other standard treatment options available.
Not a fit: Patients with non-recurrent or stable meningiomas or those who have other effective treatment alternatives may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a more effective option for patients with recurrent or progressive meningiomas, potentially improving their outcomes.
How similar studies have performed: Previous studies using peptide receptor radionuclide therapy have shown promising results in treating similar conditions, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Basel, Canton of Basel-City
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.