Treatment of Recurrent or Progressive Meningiomas With the Radiolabelled Somatostatin Antagonist 177Lu-satoreotide

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    18
  • sponsor
    University Hospital, Basel, Switzerland
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Updated on 7 October 2022
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ct scan
somatostatin
karnofsky performance status
dotatoc
peptide receptor radionuclide therapy

Summary

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. In this study, the therapeutic index of a standard and newly developed radiolabelled somatostatin antagonist will be evaluated and compared in PRRT. In a second step, safety and efficacy of the latter will be assessed.

Description

The somatostatin receptor subtype 2 (sstr2) has been identifies as a peptide hormone receptor that is highly expressed in 70 - 100% of meningiomas representing an attractive target for so called "theranostic" applications combining molecular imaging and targeted radionuclide therapy with radiolabelled somatostatin analogues.The newly developed radiolabelled somatostatin antagonist 177Lu-DOTA-JR11 has been shown to exert a high binding affinity to sstr2 suggesting a higher efficacy in the treatment of advanced meningiomas than the currently available somatostatin analogues (e.g. 177Lu-DOTATOC, 177Lu-DOTATATE).Therefore, the hypothesis has been postulated that 177LuDOTA-JR11 has an improved therapeutic index (tumour-to-dose limiting organ dose ratios) compared to 177Lu-DOTATOC, and that it can be safely used for PRRT in patients with advanced, recurrent or progressive meningiomas. The aim of this 2-step Phase 0 / Phase I/II study is to a) evaluate in the same meningioma patients the therapeutic index (tumour-to-dose limiting organ dose ratios) of 177Lu-DOTA-JR11 in comparison to 177Lu-DOTATOC and b) based on the previous results, to evaluate safety and preliminary efficacy of PRRT with 177Lu-DOTA-JR11.

Details
Condition Meningioma, Meningiomas
Treatment 177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over), 177Lu-DOTATOC (Phase 0); Cycle 1 and Cycle 2 (cross-over), Cycle 3 and 4, 177Lu-DOTA-JR11 (Phase I/II)
Clinical Study IdentifierNCT04997317
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on7 October 2022

Eligibility

 Yes No Not Sure

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
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