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

Primary Purpose

Liver Neoplasms

Status

Completed

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Holmium-166 polylactic microspheres

About this trial

This is an interventional treatment trial for Liver Neoplasms focused on measuring liver tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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 within the last 4 weeks before the start of study therapy.
The last dose of prior chemotherapy has been received less than 4 weeks prior the start of study therapy.
Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
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.
Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
Glomerular filtration rate <35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN.
Leukocytes < 4.0 109/l and/or platelet count < 150 109/l.
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.
Pregnancy or breast feeding (women of child-bearing potential).
Patients suffering from diseases with a increased chance of liver toxicity, such as primary biliary 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.
Previous enrolment in the present study or previous treatment with radioembolisation.

Sites / Locations

Department of Radiology University Medical Center Utrecht

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Holmium-166 MS radioembolization

Arm Description

Single radioembolization met Holmium-166 polylactic microspheres administered

Outcomes

Primary Outcome Measures

Target lesions tumour response

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

Clinical evaluation and laboratory testing after week 1,3,6,9,12,24,36,52

Full Information

NCT ID

NCT01612325

First Posted

June 1, 2012

Last Updated

August 26, 2015

Sponsor

UMC Utrecht

1. Study Identification

Unique Protocol Identification Number

NCT01612325

Brief Title

Radioactive Holmium Microspheres for the Treatment of Unresectable Liver Metastases

Acronym

HEPAR-2

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

UMC Utrecht

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Neoplasms

Keywords

liver tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Holmium-166 MS radioembolization

Arm Type

Experimental

Arm Description

Single radioembolization met Holmium-166 polylactic microspheres administered

Intervention Type

Device

Intervention Name(s)

Holmium-166 polylactic microspheres

Intervention Description

Radioembolisation with 600 mg of Holmium-166 microspheres with a patient liver size adjusted activity. The desired whole liver dose is 60 Gy.

Primary Outcome Measure Information:

Title

Target lesions tumour response

Description

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

Time Frame

3 month after treatment

Secondary Outcome Measure Information:

Title

Toxicity according CTC v 4 criteria

Description

Clinical evaluation and laboratory testing after week 1,3,6,9,12,24,36,52

Time Frame

Clinical evaluation after 1,3,6,9,12,24,36,52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: 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 within the last 4 weeks before the start of study therapy. The last dose of prior chemotherapy has been received less than 4 weeks prior the start of study therapy. Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy. 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. Serum bilirubin > 1.5 x Upper Limit of Normal (ULN). Glomerular filtration rate <35 ml/min, determined according to the Modification of Diet in Renal Disease formula. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN. Leukocytes < 4.0 109/l and/or platelet count < 150 109/l. 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. Pregnancy or breast feeding (women of child-bearing potential). Patients suffering from diseases with a increased chance of liver toxicity, such as primary biliary 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. Previous enrolment in the present study or previous treatment with radioembolisation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bernard Zonnenberg, MD, PhD

Organizational Affiliation

UMCU Utrecht Netherlands

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Martin Hendriks, MD, PhD

Organizational Affiliation

UMCU Utrecht, Netherlands

Official's Role

Study Director

Facility Information:

Facility Name

Department of Radiology University Medical Center Utrecht

City

Utrecht

ZIP/Postal Code

3584CX

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

20550679

Citation

Smits ML, Nijsen JF, van den Bosch MA, Lam MG, Vente MA, Huijbregts JE, van het Schip AD, Elschot M, Bult W, de Jong HW, Meulenhoff PC, Zonnenberg BA. Holmium-166 radioembolization for the treatment of patients with liver metastases: design of the phase I HEPAR trial. J Exp Clin Cancer Res. 2010 Jun 15;29(1):70. doi: 10.1186/1756-9966-29-70.

Results Reference

background

PubMed Identifier

24819055

Citation

Elschot M, Nijsen JF, Lam MG, Smits ML, Prince JF, Viergever MA, van den Bosch MA, Zonnenberg BA, de Jong HW. ((9)(9)m)Tc-MAA overestimates the absorbed dose to the lungs in radioembolization: a quantitative evaluation in patients treated with (1)(6)(6)Ho-microspheres. Eur J Nucl Med Mol Imaging. 2014 Oct;41(10):1965-75. doi: 10.1007/s00259-014-2784-9. Epub 2014 May 13.

Results Reference

derived

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Radioactive Holmium Microspheres for the Treatment of Unresectable Liver Metastases

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