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

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ClinicalTrials.gov Identifier: NCT02088645
Recruitment Status : Recruiting
First Posted : March 17, 2014
Last Update Posted : November 29, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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 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.


Condition or disease Intervention/treatment Phase
Thyroid Cancer, Medullary Drug: 177Lu-PP-F11N Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.
Study Start Date : April 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018


Arms and Interventions

Arm Intervention/treatment
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 3 x max. 15 GBq 177Lu-PP-F11N (increasing activity in 1 GBq steps in groups of three patients). All patients with or without Physiogel, depending on the results of the phase 0 study.

Drug: 177Lu-PP-F11N
Other Names:
  • Minigastrin analogue
  • Gastrin analogue
  • Cholecystokinin-2 receptor ligand


Outcome Measures

Primary Outcome Measures :
  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 Measures :
  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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088645


Contacts
Contact: Christof Rottenburger, Dr. med. 0041613286551 Christof.Rottenburger@usb.ch
Contact: Damian Wild, Prof Dr Dr 0041613286683 damian.wild@usb.ch

Locations
Switzerland
University Hospital Basel, Clinic for radiology and nuclear medicine Recruiting
Basel, Switzerland, 4031
Contact: Christof Rottenburger, Dr. med.    0041613286551    christof.rottenburger@ubs.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Krebsforschung Schweiz, Bern, Switzerland
Paul Scherrer Institut, Villigen, Switzerland
University Hospital, Zürich
University Hospital Freiburg
Investigators
Principal Investigator: Christof Rottenburger, Dr. med. University Hospital, Basel, Switzerland
Study Director: Damian Wild, Prof Dr Dr University Hospital, Basel, Switzerland
More Information

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02088645     History of Changes
Other Study ID Numbers: KFS-3170-02-2013
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Keywords provided by University Hospital, Basel, Switzerland:
Calcitonin
Medullary thyroid carcinoma
Peptide receptor radionuclide therapy
Gastrin
Cholecystokinin-2 receptor

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Gastrins
Cholecystokinin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cholagogues and Choleretics
Gastrointestinal Agents