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New treatment option for Meningioma
Official title Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-satoreotide
ClinicalTrials.gov ID: NCT04997317
What this study is testing
What is 177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over)?
177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for meningioma.
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
- Meningiomas are known to be the most frequent intracranial neoplasms and account for approx. 25-33% of all intracranial tumours.Targeted radionuclide therapy with radiolabelled somatostatin analogues, also called Peptide Receptor Radionuclide Therapy (PRRT), has proven to be an effective treatment in metastatic intestinal neuroendocrine tumours and is currently used in advanced, recurrent or progressive meningiomas with promising results.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Male participants must use medically accepted contraceptive during and till 3 months after treatment
- The participants' Karnofsky Performance Status must be ≥ 60
You likely can't join if
- 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...
- Any extensive Radiotherapy involving bone marrow over the last 3 months before inclusion to the study
- Chemotherapy in the last 2 months before inclusion
See the full eligibility 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...
- 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)...
- 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%]...
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Canton of Basel-City, Switzerland
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Canton of Basel-City, Switzerland. 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.