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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01031784
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
B.A. Zonnenberg, UMC Utrecht

Tracking Information
First Submitted Date  ICMJE December 14, 2009
First Posted Date  ICMJE December 15, 2009
Last Update Posted Date January 31, 2012
Study Start Date  ICMJE December 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2009)
Toxicity of Ho-166 poly lactic microspheres using CTC vs 3 criteria [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2010)
tumor response according to RECIST criteria [ Time Frame: 12 weeks ]
tumor size will be determined using CT scans and MRI
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radioactive Holmium Microspheres for the Treatment of Liver Metastases
Official Title  ICMJE Radioactive Holmium Microspheres for the Treatment of Patients With Non-resectable Liver Metastases of Mixed Origin; a Single Center, Interventional, Non-randomized, Open Label, Safety Study.
Brief Summary The HEPAR study is aimed at determining the safety of radioactive holmium containing microspheres for the treatment of tumors in the liver. These microspheres will be administered by infusion in the liver artery using a arterial catheter in the femoral artery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liver Metastasis
  • Liver Tumors
Intervention  ICMJE
  • Device: holmium-166 poly lactic acid microspheres
    Intra arterial administration of radioactive Holmium 166 microspheres; 600 mg with a specific activity ranging from 1260 MBq per kilo liver weight to 5040 MBq in the highest dose
  • Device: holmium 166 microspheres
    intra arterial administration of holmium 166 microsphers in the hepatic artery
Study Arms  ICMJE Experimental: Holmium-166 microspheres, intra-arterial
intra-arterial administration of holmium-166 microspheres in the liver
Interventions:
  • Device: holmium-166 poly lactic acid microspheres
  • Device: holmium 166 microspheres
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2009)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients meeting the following criteria may enter the study:

  1. Patients must have given written informed consent.
  2. Female or male aged 18 years and over.
  3. Confirmed histological diagnosis of metastatic malignancy with dominant liver metastases without standard therapeutic options for treatment including chemotherapy or surgery. Dominant liver metastases are defined (according to the Response Evaluation Criteria in Solid Tumors (RECIST) methodology, see Appendix IV) as the diameter of all metastases in the liver must be more than 200% of the sum of the diameters of all soft tissue lesions outside the liver.
  4. Life expectancy of 12 weeks or longer.
  5. World Health Organisation (WHO) Performance status 0-2 (see Appendix III).
  6. One or more measurable lesions at least 10 mm in the longest diameter by spiral Computed Tomography (CT) scan (5 mm slice thickness) according to the RECIST criteria.
  7. Negative pregnancy test for women of childbearing potential. -

Exclusion Criteria:

Patients meeting any of the following criteria cannot enter the study:

  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 3.0, see Appendix II) grade 2 from previous anti-cancer therapy.
  6. Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
  7. Serum creatinine > 185 µmol/L.
  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. Comorbidity with a grave prognosis (estimated survival <3 months) and/or worse then the basic disease for which the patients will be included in the study.
  13. Patients with abnormalities of the bile ducts (such as stents) with a increased chance of infections of the bile ducts.
  14. Patients suffering from diseases with a increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum.
  15. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
  16. Patients who are declared incompetent.
  17. Previous enrolment in the present study or previous treatment with radio-embolisation.
  18. Treated with an investigational agent within 42 days prior to starting study treatment.
  19. 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.
  20. 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.
  21. Evidence of portal hypertension, splenomegaly or ascites.
  22. Body weight over 150 kg.
  23. Active hepatitis (B and/or C).
  24. Liver weight > 3 kg (determined by software using CT data).
  25. Allergy for i.v. contrast used (Visipaque®).
  26. MRI contra-indications: severe claustrophobia, metal shrapnel, implanted pacemaker and/or neurostimulators.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01031784
Other Study ID Numbers  ICMJE 08-450
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party B.A. Zonnenberg, UMC Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bernard Zonnenberg, MD, Ph.D UMC Utrecht
PRS Account UMC Utrecht
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP