177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.
Conditions
Thyroid Cancer, Medullary
Conditions: official terms
Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
Calcitonin, Medullary thyroid carcinoma, Peptide receptor radionuclide therapy, Gastrin, Cholecystokinin-2 receptor
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: 177Lu-PP-F11N
Type: Drug
Overall Status
Recruiting
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 we 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 we 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 - 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 < 70 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 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
Location
University Hospital Basel, Clinic for radiology and nuclear medicine
Basel, Switzerland
Status: Recruiting
Contact: Christof Rottenburger, Dr. med. - 0041613286551 - christof.rottenburger@ubs.ch
Start Date
April 2015
Sponsors
University Hospital, Basel, Switzerland
Source
University Hospital, Basel, Switzerland
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page