JOURNAL ONKOLOGIE – STUDIE
Lumed
Christof Rottenburger, Dr. med.
Principal Investigator
University Hospital, Basel, Switzerland
Damian Wild, Prof Dr Dr
Study Director
University Hospital, Basel, Switzerland
Christof Rottenburger, Dr. med.
Kontakt:
Phone: 0041613286551
E-Mail: Christof.Rottenburger@usb.ch» Kontaktdaten anzeigen
Damian Wild, Prof Dr Dr
Kontakt:
Phone: 0041613286683
E-Mail: damian.wild@usb.ch» Kontaktdaten anzeigen
Studienlocations
University Hospital Basel, Clinic for radiology and nuclear medicine
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Christof Rottenburger, Dr. med.
Phone: 0041613286551
E-Mail: christof.rottenburger@ubs.ch» Ansprechpartner anzeigen
The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.
In the pilot (phase 0) study investigators will correlate the tumour detection rate with the surgery and histology (proof of concept study). Furthermore, kidney protection and dosimetry studies will be performed in order to determine the kidney protection protocol and starting activity for the dose escalation study in the following, dose escalation (phase I) study. In the phase I study investigators will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC. Furthermore, correlation with tumour radiation dose and treatment response as well as organ radiation doses and maximal tolerated dose will be performed in order to allow prospective individual patient tailored therapy planning. In the phase I study, participation is additionally possible for patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2).
Phase 0 study
- Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy or
- Patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2) with low or missing expression of SST2-receptor and progressive disease within the last 6 months according to RECIST 1.1
- Age > 18 years
- Informed consent
Phase I study
- Diagnostic, contrast medium enhanced CT scan neck/thorax/abdomen, not older than 4 weeks
- Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy- Age > 18 Years
- Informed consent
- Curative surgical therapy not possible
Exclusion Criteria:
Phase 0 study
- Medication with Vandetanib 3 weeks before the study and during the study
- Renal failure (calculated glomerular filtration rate (GFR) < 60 ml/min per 1.73 m2 body surface).
- Bone marrow failure (thrombocytes < 70 000/μl, leucocytes < 2 500/μl, hemoglobin < 8 g/dl).
- Pregnancy and breast feeding
- Knows allergic reaction on Physiogel or other gelatine products
- Known, serious side reaction in the case of a former application of pentagastrin
- Active, second malignancy oder remission after second malignancy < 5 years
Phase I study
- Medication with Vandetanib 3 weeks before the study and during the study
- Renal failure (calculated GFR < 50 ml/min per 1.73 m2 body surface).
- Bone marrow failure (thrombocytes < 100 000/μl, leucocytes < 3 000/μl, hemoglobin < 10 g/dl).
- Pregnancy and breast feeding
- Known, serious side reaction in the case of a former application of pentagastrin
- Active, second malignancy oder remission after second malignancy < 5 years
1. Phase 0: Scintigraphic visualisation rate (Time Frame - up to 4 weeks):
Phase 0 study: Evaluation of the scintigraphic visualisation of metastases after test injection, verification of 177Lu-PP-F11N uptake in metastases and correlation with surgery/histology if possible (poof of principle study).
2. Phase I: Maximum tolerated dose (Time Frame - Up to 9 months):
Phase I study: Determination of the maximum tolerated dose (MTD)
Secondary outcome:
1. Phase 0: Tumour-to-kidney radiation doses (Time Frame - 8 and 16 weeks):
Evaluation of the kidney radiation dose and the tumour-to-kidney radiation dose ratios with and without kidney protection (Physiogel). Composite measure.
2. Phase 0: Radiation doses (Time Frame - 8 and 16 weeks):
Calculation of tumour and organ radiation doses.
3. Phase 0: In vivo stability (Time Frame - 8 and 16 weeks):
Evaluation of in vivo stability of 177Lu-PP-F11N.
4. Phase 0: Metabolites (Time Frame - 8 and 16 weeks):
Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion.
5. Phase I: Side reactions (Time Frame - 8, 16 and 24 weeks):
Evaluation of side reactions of 177Lu-PP-F11N.
6. Phase 1: Biochemical response (Time Frame - For the duration of 24 months.):
Evaluation of biochemical response (decrease of calcitonin and calculation of calcitonin doubling time).
7. Phase I: Morphological response (Time Frame - 0, 3 and 12 months):
Evaluation of morphological therapy response (RECIST criteria).
8. Phase I: Tumour detection rate (Time Frame - 8, 16 and 24 weeks):
Determination of the tumour detection rate and correlation with surgery/histology, if possible.
9. Phase I: Organ radiation doses (Time Frame - 8, 16 and 24 weeks):
Calculation of organ radiation doses after therapy and correlation with the determined MTD (composite measure).
10. Phase 1: Overall survival (Time Frame - Up to 5 years):
Determination of overall survival of patients after therapy.
11. Phase 1: In vivo stability (Time Frame - 8, 16 und 24 weeks):
Evaluation of in vivo stability of 177Lu-PP-F11N.
12. Phase 1: Metabolites (Time Frame - 8, 16 and 24 weeks):
Measurement of the metabolites of 177Lu-PP-F11N.
177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.
Rekrutierend
NCT-Nummer:
NCT02088645
Studienbeginn:
April 2015
Letztes Update:
05.08.2020
Wirkstoff:
177Lu-PP-F11N
Indikation (Clinical Trials):
Thyroid Diseases, Thyroid Neoplasms, Neuroendocrine Tumors, Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 1
Sponsor:
University Hospital, Basel, Switzerland
Collaborator:
Krebsforschung Schweiz, Bern, Switzerland, Center for Proton Therapy, Paul Scherrer Institute, Villigen, Switzerland, University Hospital, Zürich, University Hospital Freiburg,
Studienleiter
Principal Investigator
University Hospital, Basel, Switzerland
Study Director
University Hospital, Basel, Switzerland
Kontakt
Kontakt:
Phone: 0041613286551
E-Mail: Christof.Rottenburger@usb.ch» Kontaktdaten anzeigen
Kontakt:
Phone: 0041613286683
E-Mail: damian.wild@usb.ch» Kontaktdaten anzeigen
Studienlocations
(1 von 1)
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Christof Rottenburger, Dr. med.
Phone: 0041613286551
E-Mail: christof.rottenburger@ubs.ch» Ansprechpartner anzeigen
Studien-Informationen
Brief Summary:The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.
In the pilot (phase 0) study investigators will correlate the tumour detection rate with the surgery and histology (proof of concept study). Furthermore, kidney protection and dosimetry studies will be performed in order to determine the kidney protection protocol and starting activity for the dose escalation study in the following, dose escalation (phase I) study. In the phase I study investigators will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC. Furthermore, correlation with tumour radiation dose and treatment response as well as organ radiation doses and maximal tolerated dose will be performed in order to allow prospective individual patient tailored therapy planning. In the phase I study, participation is additionally possible for patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2).
Ein-/Ausschlusskriterien
Inclusion Criteria:Phase 0 study
- Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy or
- Patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2) with low or missing expression of SST2-receptor and progressive disease within the last 6 months according to RECIST 1.1
- Age > 18 years
- Informed consent
Phase I study
- Diagnostic, contrast medium enhanced CT scan neck/thorax/abdomen, not older than 4 weeks
- Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy- Age > 18 Years
- Informed consent
- Curative surgical therapy not possible
Exclusion Criteria:
Phase 0 study
- Medication with Vandetanib 3 weeks before the study and during the study
- Renal failure (calculated glomerular filtration rate (GFR) < 60 ml/min per 1.73 m2 body surface).
- Bone marrow failure (thrombocytes < 70 000/μl, leucocytes < 2 500/μl, hemoglobin < 8 g/dl).
- Pregnancy and breast feeding
- Knows allergic reaction on Physiogel or other gelatine products
- Known, serious side reaction in the case of a former application of pentagastrin
- Active, second malignancy oder remission after second malignancy < 5 years
Phase I study
- Medication with Vandetanib 3 weeks before the study and during the study
- Renal failure (calculated GFR < 50 ml/min per 1.73 m2 body surface).
- Bone marrow failure (thrombocytes < 100 000/μl, leucocytes < 3 000/μl, hemoglobin < 10 g/dl).
- Pregnancy and breast feeding
- Known, serious side reaction in the case of a former application of pentagastrin
- Active, second malignancy oder remission after second malignancy < 5 years
Studien-Rationale
Primary outcome:1. Phase 0: Scintigraphic visualisation rate (Time Frame - up to 4 weeks):
Phase 0 study: Evaluation of the scintigraphic visualisation of metastases after test injection, verification of 177Lu-PP-F11N uptake in metastases and correlation with surgery/histology if possible (poof of principle study).
2. Phase I: Maximum tolerated dose (Time Frame - Up to 9 months):
Phase I study: Determination of the maximum tolerated dose (MTD)
Secondary outcome:
1. Phase 0: Tumour-to-kidney radiation doses (Time Frame - 8 and 16 weeks):
Evaluation of the kidney radiation dose and the tumour-to-kidney radiation dose ratios with and without kidney protection (Physiogel). Composite measure.
2. Phase 0: Radiation doses (Time Frame - 8 and 16 weeks):
Calculation of tumour and organ radiation doses.
3. Phase 0: In vivo stability (Time Frame - 8 and 16 weeks):
Evaluation of in vivo stability of 177Lu-PP-F11N.
4. Phase 0: Metabolites (Time Frame - 8 and 16 weeks):
Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion.
5. Phase I: Side reactions (Time Frame - 8, 16 and 24 weeks):
Evaluation of side reactions of 177Lu-PP-F11N.
6. Phase 1: Biochemical response (Time Frame - For the duration of 24 months.):
Evaluation of biochemical response (decrease of calcitonin and calculation of calcitonin doubling time).
7. Phase I: Morphological response (Time Frame - 0, 3 and 12 months):
Evaluation of morphological therapy response (RECIST criteria).
8. Phase I: Tumour detection rate (Time Frame - 8, 16 and 24 weeks):
Determination of the tumour detection rate and correlation with surgery/histology, if possible.
9. Phase I: Organ radiation doses (Time Frame - 8, 16 and 24 weeks):
Calculation of organ radiation doses after therapy and correlation with the determined MTD (composite measure).
10. Phase 1: Overall survival (Time Frame - Up to 5 years):
Determination of overall survival of patients after therapy.
11. Phase 1: In vivo stability (Time Frame - 8, 16 und 24 weeks):
Evaluation of in vivo stability of 177Lu-PP-F11N.
12. Phase 1: Metabolites (Time Frame - 8, 16 and 24 weeks):
Measurement of the metabolites of 177Lu-PP-F11N.
Geprüfte Regime
- 177Lu-PP-F11N (Minigastrin analogue / Gastrin analogue / Cholecystokinin-2 receptor ligand / )
Quelle: ClinicalTrials.gov
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