A safety study of Lutathera in newly diagnosed glioblastoma patients in combination with currently approved treatments or in patients with recurrent glioblastoma as a single agent.
Résumé de l'étude
Glioblastoma (GB) is the most common malignant tumor of the central nervous system. Given the available data, GB could be a plausible target for targeted peptide receptor radionuclide therapy, Lutathera. Lutathera was approved in 2019 for the treatment of inoperable or metastatic, progressive gastroenteropancreatic neuroendocrine tumors (NET) with sufficient expression of somatostatin receptors on tumor cells in adults. A radioactive particle (Lutetium-177) is used, which is attached to a targeting ligand that specifically binds to somatostatin receptors (receptors for the hormone somatostatin) on the surface of tumor cells. Due to the presence of somatostatin receptors in GB samples, Lutathera could broadly irradiate tumor margins. This open-label, multicenter study aims to determine the recommended dose of Lutathera® in combination with standard treatment or as a single agent in three different groups of participants with glioblastoma. Eligible participants with newly diagnosed glioblastoma will be assigned to group 1 or group 2 based on the amounts of a form of biomarker (laboratory value of the MGMT biomarker). Participants with recurrent glioblastoma will be assigned to group 3. Furthermore, this study will investigate the safety of Netspot® as an imaging agent in participants with glioblastoma. Netspot® is already approved for imaging somatostatin receptors on NET cells using positron emission tomography (PET).
(BASEC)
Intervention étudiée
- All participants will be scanned during screening with Netspot® PET/CT (or PET/MRI) to check if we can use this examination as a new imaging method in patients with GB. - Participants in group 1 will receive treatment with Lutathera® in combination with standard treatment. Lutathera® will be administered in the nuclear medicine department every 4 weeks up to a total of 6 times. Radiation therapy and temozolomide will be administered 7 to 10 days after the first administration of Lutathera®. Radiation therapy will be conducted 5 days a week, followed by 2 rest days, over 6 consecutive weeks. Temozolomide will be administered orally, concurrently with radiation therapy. During the maintenance phase, the dosage of temozolomide may be increased. - Participants in group 2 will receive treatment with Lutathera® in combination with standard therapy. Lutathera® will be administered in the nuclear medicine department every 4 weeks for the first 3 doses, then every 3 weeks as a single agent, for a total of up to 6 times. Radiation therapy will be initiated 7 to 10 days after the first administration of Lutathera® and will be conducted with a dose of 2 Gy/day for 5 days a week, followed by 2 rest days, over 6 consecutive weeks. - Participants in group 3 will receive Lutathera® every 3 weeks as a single agent.
(BASEC)
Maladie en cours d'investigation
Recurrent and newly diagnosed glioblastoma (brain tumor)
(BASEC)
Common criteria: - Histologically confirmed glioblastoma - Appropriate blood values of bone marrow, electrolytes, and organ functions Newly diagnosed glioblastoma: - Presence of a gadolinium-enhanced tumor on MRI prior to surgery - Karnofsky performance status ≥ 70%. - Presence of representative tumor tissue for GB from a definitive surgery or biopsy Recurrent glioblastoma: - The participant has a first or second recurrence of their glioblastoma after standard or experimental therapy that includes prior radiation therapy. - Netspot® signal in the PET/CT or PET/MRI scan in the tumor region - Karnofsky performance status ≥ 60%. (BASEC)
Critères d'exclusion
Common criteria: - The participant is receiving additional, concurrent active therapy for glioblastoma outside of the study - Extensive leptomeningeal disease - History of another active malignant disease in the last 3 years prior to study initiation Newly diagnosed glioblastoma: - Any prior treatment of a glioma of any grade Recurrent glioblastoma: - Early progression of disease before 3 months after completion of radiation therapy - More than 2 prior systemic therapies - Prior treatment with Bevacizumab (BASEC)
Lieu de l’étude
Lausanne, Zurich
(BASEC)
Sponsor
Novartis Pharma Schweiz AG
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Medizinische Auskünfte
+41 41 763 71 11
swiss.medinfo@clutternovartis.comNovartis Pharma Schweiz AG Medical Information
(BASEC)
Informations scientifiques
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Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
28.06.2022
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination with Radiotherapy with or without Temozolomide and in Recurrent Glioblastoma as Single Agent (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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