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.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

- Patients must have given written informed consent.
- Female or male aged 18 years and over.
- Confirmed histological diagnosis of metastatic malignancy with dominant liver metastases without standard therapeutic options for treatment including chemotherapy or surgery.
- Life expectancy of 12 weeks or longer.
- World Health Organisation (WHO) Performance status 0-2.
- One or more measurable lesions at least 10 mm in the longest diameter by spiral Computed Tomography (CT) scan.
- Negative pregnancy test for women of childbearing potential.

Exclusion Criteria

- 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.
- Radiation therapy or the last dose of prior chemotherapie within the last 4 weeks before the start of study therapy.
- Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
- Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
- Serum creatinine > 185 µmol/L.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN.
- Leukocytes < 4.0 10EXP9/l and/or platelet count < 150 10EXP9/l.
- Significant cardiac event or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- 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.
- patients with abnormalities of the bile ducts (such as stents) with a increased chance of infections of the bile ducts.
- patients suffering from diseases with a increased chance of liver toxicity, such as primary biliairy cirrhosis or xeroderma pigmentosum.
- patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
- patients who are declared incompetent.
- Treated with an investigational agent within 42 days prior to starting study treatment.
- Evidence of portal hypertension, splenomegaly or ascites.
- Active hepatitis (B and/or C).
- Liver weight > 3 kg.
- Patients who have arterial variations that will not allow whole liver treatment by a single administration via the hepatic artery

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and toxicity profile of treatment with Ho-166-PLLA-MS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Tumor response.<br /><br>• Patient dosimetry.<br /><br>• Performance status.<br /><br>• Quality of Life.<br /><br>• Comparison of Tc-MAA-scan and Ho-166-PLLA-MS safety dose scan.</p><br>