177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.

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177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02088645
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital, Basel, Switzerland
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Christof Rottenburger, Dr. med.Damian Wild, Prof Dr Dr
Principal Investigator Affiliation	University Hospital, Basel, SwitzerlandUniversity Hospital, Basel, Switzerland
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Switzerland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Thyroid Cancer, Medullary, Neuroendocrine Tumor of the Lung Grade 1 and 2, Neuroendocrine Tumor of the Thymus Grade 1 and 2, Neuroendocrine Tumor GEP Grade 1-3
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Phase 0: One arm; Phase I: One arm

Phase 0: 6 patients, intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without Physiogel (crossover) Phase I: expected 12 - 18 patients, intravenous application of max. 6 x 7-8 GBq 177Lu-PP-F11N (increasing number of applications by one in groups of three patients). All patients with or without Physiogel, depending on the results of the phase 0 study.

Interventions

Drug: - 177Lu-PP-F11N

Contact a Trial Team

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