Expanded Access Study of Melphalan With Delcath CS-PHP System in Patients With Ocular/Cutaneous Melanoma Mets to Liver

NO_LONGER_AVAILABLE

Conditions studied: Metastatic Liver Cancer, Ocular Melanoma, Cutaneous Melanoma

In brief

The safety and efficacy of CS-PHP-melphalan has been evaluated in a phase 3 trial conducted in the same patient population as well as using the same melphalan dosing as proposed in this study. This expanded access protocol will provide an experimental alternative treatment option for both physicians and patients until the Delcath CS-PHP System receives marketing approval.

Key facts

Study ID

NCT01728051

Run by

Delcath Systems Inc.

Last updated by the study team

2013-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven ocular/cutaneous melanoma with liver-dominant unresectable metastatic disease, defined as limited extra-hepatic disease and hepatic involvement which would, in the Investigator's opinion, result in morbidity and eventual mortality. Limited extra-hepatic disease considered acceptable includes:
• up to 4 pulmonary nodules, each <1cm in diameter
• retroperitoneal lymph nodes <1cm in diameter
• resectable skin or subcutaneous metastases
• asymptomatic bone metastases that have been, or can be, palliated with external beam radiation therapy
• a solitary metastasis to any site that can be resected with limited morbidity or controlled with radiation
• ≥1 measurable hepatic lesion per RECIST 1.1
• Vasculature compatible with insertion of CS-PHP catheters, per baseline abdominal MRA
• ECOG PS 0-2

You may not qualify if…

• Chemotherapy, radiotherapy, or biologic therapy for the malignancy ≤1 month prior to 1st CS-PHP-melphalan infusion
• Extensive prior radiotherapy, defined as treatment to ≥50% of marrow-containing bones
• Immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids taken currently or ≤3 mths prior to 1st CS-PHP-melphalan infusion
• Received an investigational product ≤30 days prior to the 1st CS-PHP-melphalan infusion
• History of orthotopic liver transplantation, untreated gastrinoma (i.e. gastric acid hypersecretion) or prior Whipple procedure
• Not recovered from side effects of prior therapy to ≤ Grade 1 NCI CTCAE 4.03
• Child's B or C cirrhosis, or clinical evidence of portal hypertension
• Patients with >50% of liver replaced by tumor, histologic evidence of hepatic dysfunction seen by laparoscopic liver biopsy
• History or evidence of clinically significant cardiac disease such as symptomatic arrhythmia, angina/ischemia, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty, uncontrolled atrial fibrillation, CHF with a left ventricular ejection fraction <40%, uncontrolled hypertension (SBP >190 mmHg or DBP >100 mmHg), HR outside normal range of 50-100 bpm for women and 45-100 bpm for men
• History/evidence of clinically significant pulmonary or cardiac disease incompatible with fitness to undergo general anesthesia
• Uncontrolled diabetes mellitus or hypo/hyperthyroidism
• Active uncontrolled infection
• History of bleeding disorders or known unresolved venous shunting
• Requirement for ongoing chronic anticoagulation
• Evidence of intracranial abnormalities resulting in risk for bleeding with anticoagulation
• History of alcohol or drug abuse ≤6 mths
• Other malignancy within 3 yrs before enrollment with the exception of curatively treated basal or squamous cell carcinoma of the skin, or curatively treated cervical, breast carcinoma in situ or prostate cancer
• History of hypersensitivity to: melphalan or its components; iodine contrast that cannot be controlled by premedication with antihistamines and steroids; latex
• Known hypersensitivity to heparin in the presence of heparin-induced thrombocytopenia antibodies
• Inadequate hematological or renal function as indicated by any of the following:
• Platelets <100,000/mm3
• Hb ≤10 g/dL
• Neutrophils <2,000/mm3
• S Creat >1.5 mg/dL or measured creatinine clearance <60 mL/min/1.73 m2
• Inadequate liver function as indicated by any of the following:

Where it is running

• John Wayne Cancer Institute at Saint John's Health Center — Santa Monica, California, United States
• Sky Ridge Medical Center — Englewood, Colorado, United States
• H. Lee Moffitt Cancer Center and Research Institute at University of South Florida — Tampa, Florida, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Carol G. Simon Cancer Center at Morristown Memorial Hospital — Morristown, New Jersey, United States
• University of Pittsburg Cancer Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.