Primary objective:To establish the safety and toxicity profile of treatment with Ho-166-PLLA-MS.Secondary objectives:• To evaluate tumor response. • To evaluate patient dosimetry. • To evaluate performance status.• To evaluate Quality of Life (QOL…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and toxicity profile of treatment with Ho-166-PLLA-MS.
Secondary outcome
• Tumor response.
• Patient dosimetry.
• Performance status.
• Quality of Life.
• Comparison of Tc-MAA-scan and Ho-166-PLLA-MS safety dose scan.
Background summary
A significant need for new treatment options for dominant liver metastases is
recognized, because survival of patients with unresectable liver disease is
poor. The preclinical phase of studies with Ho-166-PLLA-MS has been
successfully completed and now clinical studies for evaluation of safety and
efficacy are warranted.
Study objective
Primary objective:
To establish the safety and toxicity profile of treatment with Ho-166-PLLA-MS.
Secondary objectives:
• To evaluate tumor response.
• To evaluate patient dosimetry.
• To evaluate performance status.
• To evaluate Quality of Life (QOL).
• To compare Tc-MAA-scan with Ho-166-PLLA-MS safety dose scan.
Study design
Interventional, treatment, non-randomized, open label uncontrolled, safety
study.
Intervention
Ho-166-PLLA-MS will be administered via a catheter (type Cobra glide-catheter
(Cook) 5 French) during angiography.
Study burden and risks
The burden for the patient consits of:
1 screening visite, 1 hospital admission for 24 hours, 1 hospital admission for
48 hours, 12 outpatient visits, 15 blood samples for safety, 3 HRQOL
questionnaires. Physical examination at every visit. 2 angiographies, CT-scans,
PET-scans and MRI-scans. 1 technetiumscan, 1 non-contrast enhanced MRI of
limited duration and 2 holmiumscans. 1 time 48-hours and 2 times 24-hours urine
collection.
Risks
Apart from the angiographic procedures and device related toxicity as described
in chapter 7, standard radiological and nuclear procedures are also used that
may have their inherent side effects. For the frequent blood sampling an
indwelling cannula may be used and this may be accompanied by mild bruising and
also, in rare cases, by transient inflammation of the vessel wall. After
initial irritation, the presence of an indwelling cannula is usually painless
and hardly noticeable. The same applies to single vein punctures for blood
sampling. When needed, the use of a urethral catheter may also cause infection.
The total amount of blood withdrawn during the study will be up to 100 ml
(normal blood donation: 500 ml).
Benefits
It is anticipated that treatment with radioactive microspheres will reduce
tumor size and will improve quality of life as known from literature from
yttrium-90. It is anticipated that the gamma emission of the radioactive
Holmium will improve the safety of the procedure. Also the difference in
specific activity of Ho-166-PLLA-MS compared to the currently available
yttrium-90 may improve therapeutic results.
Participation in this study may possibly produce useful scientific data for the
future. Regular medical check-ups during the study can be seen as an additional
benefit. The number of visits (15) is comparable to a standard chemotherapy
protocol. However, the scheduling is different.
Heidelberglaan 100
3584 CX UTRECHT
Nederland
Heidelberglaan 100
3584 CX UTRECHT
Nederland
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25956.041.08 |