Radioactive Holmium Microspheres for the Treatment of Unresectable Liver Metastases (HEPAR 2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by UMC Utrecht
Sponsor:
Information provided by (Responsible Party):
B.A. Zonnenberg, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01612325
First received: June 1, 2012
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

Radioembolisation is a known method for the treatment of liver tumors and or livermetastases. Currently small beadlets called microspheres are used that are loaded with the beta radiation emitting Yttrium-90. Holmium-166 microspheres have different physical characteristics including good visualisation in gammacameras due to the gamma emission. Because of the higher specific activity higher radiation doses to the liver will be used compared to the standard Yttrium treatment. It is hypothesized that higher doses of irradiation have an improved antitumor effect.


Condition Intervention Phase
Liver Neoplasms
Device: Holmium-166 polylactic microspheres
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radioactive Holmium Microspheres for the Treatment of Patients With Unresectable Liver Metastases; a Single Center, Interventional, Non-randomized, Phase II (HEPAR II) Trial

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Target lesions tumour response [ Time Frame: 3 month after treatment ] [ Designated as safety issue: No ]
    After the administration of the Ho-166 microspheres the size of the target lesions in the liver will be determined using RECIST 1.1 criteria using CT scan


Secondary Outcome Measures:
  • Toxicity according CTC v 4 criteria [ Time Frame: Clinical evaluation after 1,3,6,9,12,24,36,52 weeks ] [ Designated as safety issue: Yes ]
    Clinical evaluation and laboratory testing after week 1,3,6,9,12,24,36,52


Estimated Enrollment: 48
Study Start Date: May 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Holmium-166 MS radioembolization
Single radioembolization met Holmium-166 polylactic microspheres administered
Device: Holmium-166 polylactic microspheres
Radioembolisation with 600 mg of Holmium-166 microspheres with a patient liver size adjusted activity. The desired whole liver dose is 60 Gy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

List of inclusion criteria:

  • 1. Patients must have given written informed consent.
  • 2. Female or male aged 18 years and over.
  • 3. Diagnosis of metastatic malignancy to the liver and no detectable malignant disease outside the liver or diagnosis of metastatic malignancy to the liver with limited disease outside the liver (i.e. liver-dominant disease) defined as the sum of the diameters of all metastases in the liver to be more than 200% of the sum of the diameters of all soft tissue lesions outside the liver.
  • 4. Patient is not amenable for standard therapies (other than radioembolisation) or patient refuses standard therapies for reasons of toxicity
  • 5. Life expectancy of 12 weeks or longer.
  • 6. World Health Organisation (WHO) Performance status 0-2 (see Appendix III).

List of exclusion criteria:

  1. 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.
  2. Radiation therapy within the last 4 weeks before the start of study therapy.
  3. The last dose of prior chemotherapy has been received less than 4 weeks prior the start of study therapy.
  4. Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
  5. Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.0, see Appendix II) grade 2 from previous anti-cancer therapy.
  6. Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
  7. Glomerular filtration rate <35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
  8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN.
  9. Leukocytes < 4.0 109/l and/or platelet count < 150 109/l.
  10. 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.
  11. Pregnancy or breast feeding (women of child-bearing potential).
  12. Patients suffering from diseases with a increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum.
  13. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
  14. Patients who are declared incompetent.
  15. Previous enrolment in the present study or previous treatment with radioembolisation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612325

Contacts
Contact: Bernard A Zonnenberg, MD, Ph D + 31 88 7555555 ext 53232 b.zonnenberg@umcutrecht.nl
Contact: Maurice A van den Bosch, Prof. MD PhD + 31 88 7555555 ext 54755 mbosch@umcutrecht.nl

Locations
Netherlands
Department of Radiology University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584CX
Principal Investigator: Bernard A Zonnenberg, MD, PhD         
Sub-Investigator: Maurice A van den Bosch, Prof. MD PhD         
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Bernard Zonnenberg, MD, PhD UMCU Utrecht Netherlands
Study Director: Martin Hendriks, MD, PhD UMCU Utrecht, Netherlands
  More Information

Publications:
Responsible Party: B.A. Zonnenberg, principal investigator, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01612325     History of Changes
Other Study ID Numbers: UMCU-11-538
Study First Received: June 1, 2012
Last Updated: July 31, 2014
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by UMC Utrecht:
liver tumors

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 01, 2014