Safety of Percutaneous Hepatic Perfusion with Melphalan in Patients with Unresectable Liver Metastases from Ocular Melanoma Using the Delcath Systems’ Second-Generation Hemofiltration System: A Prospective Non-randomized Phase II Trial

e20008 Background: Patients with unresectable liver metastases from ocular melanoma have a poor prognosis with just 10% surviving 1 year with standard treatments. High-dose melphalan via percutaneous hepatic perfusion (PHP) and filtration system (ChemoSat, Delcath Inc.) is licensed in Europe for treatment of liver-only metastases from ocular melanoma and neuroendocrine tumours. Ipilimumab (Ipi), anti-CTLA4 immunotherapy is licensed in US and Europe for treatment of metastatic malignant melanoma. A 32-year-old man was referred to our unit with unresectable liver metastases from primary ocular melanoma treated 8 years earlier. Here we describe the first report of sequential ChemoSat and Ipi in this setting. Methods: With assistance of an international proctoring team, and following on-site training, we treated this patient with ChemoSat according to manufacturer’s instructions (details at meeting). There were no immediate complications or subsequent hematological or other systemic chemotherapy side-effects. On day 4, the patient developed acute epigastric pain, pyrexia, ST elevation, and elevated troponin. Cardiac ECHO, coronary angiogram, CT pulmonary angiogram, abdominal USS and gastroscopy were normal. Blood cultures were repeatedly negative. He developed acute kidney injury secondary to intravenous contrast and NSAIDs. Repeat abdominal USS showed a thickened wall of gall bladder. A diagnosis of acute chemical cholecystitis was made. His symptoms settled, kidney function improved and he was discharged on day 23 of procedure. 10 weeks post ChemoSat the patient underwent treatment with Ipi 3mg/kg i.v. day 1, q 3/52 x 4 cycles which he received without significant side-effects. Results: MRI scan of liver 8 weeks post-ChemoSat (pre-Ipi) showed the liver lesions to be unchanged. CT scan 6 weeks post-Ipi treatment showed significant improvement. Conclusions: ChemoSat treatment is feasible and safe but can cause unexpected gall-bladder toxicity. Subsequent treatment with ipilimumab seems to be effective in this single case with short-term follow up.

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Embolization of variant hepatic arteries in patients undergoing percutaneous hepatic perfusion for unresectable liver metastases from ocular melanoma

Diagnostic and Interventional Radiology ◽

10.5152/dir.2019.18138 ◽

2019 ◽

Vol 25 (6) ◽

pp. 451-458 ◽

Cited By ~ 1

Author(s):

T. Susanna Meijer ◽

◽

Lioe-Fee de Geus-Oei ◽

Christian H. Martini ◽

Fred G. J. Tijl ◽

...

Keyword(s):

Liver Metastases ◽

Ocular Melanoma ◽

Hepatic Perfusion ◽

Hepatic Arteries ◽

Unresectable Liver Metastases ◽

Percutaneous Hepatic Perfusion

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Modified FOLFOXIRI With or Without Cetuximab as Conversion Therapy in Patients with RAS / BRAF Wild‐Type Unresectable Liver Metastases Colorectal Cancer: The FOCULM Multicenter Phase II Trial

The Oncologist ◽

10.1634/theoncologist.2020-0563 ◽

2020 ◽

Author(s):

Huabin Hu ◽

Kun Wang ◽

Meijin Huang ◽

Liang Kang ◽

Wei Wang ◽

...

Keyword(s):

Colorectal Cancer ◽

Liver Metastases ◽

Phase Ii ◽

Phase Ii Trial ◽

Wild Type ◽

Conversion Therapy ◽

Multicenter Phase ◽

Unresectable Liver Metastases

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Safety and Efficacy of Intravenous Cetuximab (CET) and Hepatic Artery Infusion of Irinotecan, 5-Fluorouracil and Oxaliplatin in Patients with Unresectable Liver Metastases from Wt Kras Colorectal Cancer (CRC): Results from Optiliv European Phase II Trial

Annals of Oncology ◽

10.1016/s0923-7534(20)33179-3 ◽

2012 ◽

Vol 23 ◽

pp. ix194

Author(s):

F. Levi ◽

V. Boige ◽

P. Rougier ◽

M. Hebbar ◽

D. Smith ◽

...

Keyword(s):

Colorectal Cancer ◽

Liver Metastases ◽

Hepatic Artery ◽

Phase Ii ◽

Phase Ii Trial ◽

Hepatic Artery Infusion ◽

Safety And Efficacy ◽

Unresectable Liver Metastases

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A randomized phase II trial comparing two doses of lenalidomide for the treatment of stage IV ocular melanoma

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.e20012 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. e20012-e20012 ◽

Cited By ~ 3

Author(s):

J. B. Zeldis ◽

C. Heller ◽

G. Seidel ◽

N. Yuldasheva ◽

D. Stirling ◽

...

Keyword(s):

Phase Ii ◽

Stable Disease ◽

Phase Ii Trial ◽

Stage Iv ◽

Ocular Melanoma ◽

Eligibility Criteria ◽

Randomized Phase Ii ◽

Animal Data ◽

Disease Stabilization ◽

Grade 3

e20012 Background: Ocular melanoma is the most common primary intraocular malignancy in adults with an incidence of 4.3 new cases per million. Approximately 50% of patients will develop metastases and the mean survival of those with liver metastases is 8–10 months. There are no effective systemic therapies. Pre-clinical studies of the antiangiogenic and immunomodulatory agent, lenalidomide, have shown promise in animal models of human ocular melanoma. We therefore conducted a phase II trial comparing two doses of oral lenalidomide. Methods: Patients with stage IV ocular melanoma, who met eligibility criteria and demonstrated disease progression, were enrolled on an IRB approved prospective random assignment trial comparing 5 mg and 25 mg of lenalidomide administered once a day orally for 21 days with a 7 day recovery (one cycle). Lesions were measured at baseline and every 3 months and scored for response by RECIST criteria. Patients who completed 3 cycles were eligible for response evaluation. Patients with responding lesions or with stable disease could continue receiving the agent. Toxicity was assessed using the NCI Common Toxicity Criteria. Results: Seventeen patients (13 female, 4 male; mean age 53) met eligibility criteria and were randomized to 5 mg (9 patients) or 25 mg (8 patients) of lenalidomide. The agent was well tolerated at both doses with only three grade 3 toxicities (two decreased ANC and one rash/puritis) requiring dose adjustments. Sixteen patients were eligible for response assessments. Nine patients had progressive disease by RECIST criteria following 3 cycles of therapy. Seven patients (44%) had stable disease for a mean of 7 months (range 6–12 months). There were no RECIST defined responders. There were no differences between the two dose groups with respect to toxicity or disease stabilization. Conclusions: Lenalidomide is well tolerated at doses of 5 mg and 25 mg orally for a 21 day cycle by patients with stage IV ocular melanoma. While no responses were seen, disease stabilization for a mean of 7 months was seen in 44% of patients. This effect was consistent with the pre-clinical animal data. Based on these results, further development of lenalidomide in combination with other agents should be considered for the treatment of metastatic ocular melanoma. [Table: see text]

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