TheranosticTrials.org

Clinical Trial · NCT02067988

Holmium-166-radioembolization in NET After Lutetium-177-dotatate; an Efficacy Study

Overview

Patients with gastroenteropancreatic neuroendocrine tumours (NET) often die from intrahepatic disease or are excluded from liver-directed treatment because of extrahepatic disease. Adjuvant liver-directed treatment is warranted to control both intra- and extrahepatic disease. Patients with liver metastases of NET will be included in this study (n = 30-48).The efficacy and toxicity of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate will be studied in a non-comparative phase II study. The study is an interventional, treatment, non-randomized, open label, non-comparative, phase II study. 166Ho-RE will be performed via a catheter during angiography.

Sponsor

UMC Utrecht

Phase

Phase 2

Contacts

Marnix G Lam, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02067988

Drug / Compound

dotatate

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

radioembolization microspheres

Isotope(s):
Target(s):
  • No Explicit Target

Eligibility

Inclusion

  • World Health Organisation (WHO) Performance status 0-2.
  • Patients must have been treated with 4 cycles of 200 mCi 177Lu-dotatate, the last cycle within 8-12 weeks of 166Ho-RE.
  • Life expectancy of 12 weeks or longer.
  • Liver disease with three or more measurable liver lesions according to the RECIST 1.1 criteria.
  • Negative pregnancy test for women of childbearing potential.

Exclusion

  • Significant cardiac event (e.g. myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease ≥2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \> 5 x ULN.
  • Radiation therapy within the last 4 weeks before the start of study therapy.
  • Patients suffering from diseases with an increased chance of liver toxicity.
  • Leukocytes \< 3.0 x 109/l and/or platelet count \< 100 x 109/l.
  • Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
  • Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy.
  • Body weight over 150 kg.
  • Female patients who are not using an acceptable method of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device or tubal ligation) OR are less than 1 year postmenopausal or surgically sterile during their participation in this study (from the time they sign the consent form) to prevent pregnancy.
  • Patients with abnormalities of the bile ducts (such as stents) with an increased chance of infections of the bile ducts (papillotomy and cholecystectomy are allowed). Or evidence of extensive portal hypertension, splenomegaly, ascites or active hepatitis (B and/or C).
  • Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events grade 2 from previous anti-cancer therapy.
  • Pregnancy or nursing (women of child-bearing potential).
  • Patients who are declared incompetent.
  • Severe allergy for i.v. contrast (Visipaque®), used for CT evaluation, pre-treatment angiography and treatment angiography.
  • The last dose of prior chemotherapy has been received less than 4 weeks prior the start of study therapy.
  • Glomerular filtration rate \<35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
  • Male patients who are not surgically sterile or do not use an acceptable method of contraception during their participation in this study (from the time they sign the consent form) to prevent pregnancy in a partner.
  • Serum bilirubin \> 1.5 x Upper Limit of Normal (ULN).
  • Previous enrolment in the present study or previous treatment with RE.
  • Brain metastases or spinal cord compression, unless irradiated at least 4 weeks prior to the date of the experimental treatment and stable without steroid treatment for at least 1 week.