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Phase 3
18 Years
Not Enrolling
Melanoma, Uveal Neoplasms

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Trial Information

Uveal melanoma is the most common primary intraocular malignancy in adults. Despite
successful control of the primary tumor, metastatic disease will ultimately develop in
approximately 50% of the patients. The liver is the most common site for metastases, and
about 50% of the patients will have isolated liver metastases. These metastases are
generally refractory to systemic chemotherapy and the median survival for patients with
liver metastases is about 6 months. Regardless of treatment, the mortality rate is
approximately 90% at 2 years with only about 1% of the patients surviving more than 5 years.

Isolated hepatic perfusion (IHP) is a regional treatment that was first performed more than
40 years ago (Aust and Ausman 1960). During IHP, the liver is completely isolated from the
systemic circulation, allowing a high concentration of chemotherapy to be perfused through
the liver with minimal systemic exposure. In a previous study from our institution, IHP was
analysed based on improvements in the procedure and the results showed an improved outcome
together with minimized morbidity and mortality over time.

A phase II follow-up study confirms that IHP is a promising technique with tolerable
morbidity. There are yet no randomized trials comparing overall survival in IHP, but in an
attempt to answer this question the investigators did a register study showing a 14 months
increased survival when comparing the patients treated with IHP with the longest surviving
patients in Sweden during the same time period.

Inclusion Criteria:

1. ≥ 18 years of age

2. Signed and dated written informed consent before the start of specific protocol

3. Histologically or cytologically proven liver metastases of uveal melanoma.

4. Liver metastases measurable by MRI (thorax and abdomen) according to RECIST version
1.1 with at least one unidimensional measurable lesion ≥ 10 mm.

5. ECOG performance status of 0 or 1.

6. No previous chemotherapy, radiotherapy, or biologic therapy for uveal melanoma
metastases (ie this is first-line therapy)

7. Adequate hepatic function (defined as normal LFTs, bilirubin and PK) and abscence of
cirrhosis or portal hypertension

Exclusion Criteria:

1. Subjects will be excluded from participating if any of the following apply: More than
50% of the liver replaced by tumour.

2. Extrahepatic disease

3. Life expectancy of less than 5 months

4. Pregnancy or breastfeeding

5. Patients with active infections.

6. Patients with ischemic cardiac disease or history of congestive heart failure with an
LVEF < 40%.

7. Patients with COPD or other chronic pulmonary disease with PFT's indicating an FEV<
50% predicted for age.

8. Body mass index above 35.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

OS defined as the frequency of individuals alive at 24 months

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Roger Olofsson, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden


Sweden: Regional Ethical Review Board

Study ID:




Start Date:

June 2013

Completion Date:

June 2020

Related Keywords:

  • Melanoma
  • Uveal Neoplasms
  • Perfusion Cancer Chemotherapy, Regional
  • Neoplasms
  • Melanoma
  • Uveal Neoplasms