Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury

Phase 2

Terminated

Brief Summary: The purposes of this study are to make Omegaven® available to cancer patients with liver disease and to determine if Omegaven® can improve or prevent further liver disease. The study will also look at the effects Omegaven® has on immune function.

Detailed Description: This compassionate use study will include patients with advanced cancer requiring PN for long-term nutrition support who have developed PN-induced hepatic injury or who have existing hepatic dysfunction. Therapy with Omegaven will be provided at an initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. For patients \> 120% ideal body weight, adjusted body weight will be used. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Omegaven will be co-administered via a y-site infusion, with containers being changed every 12 hours. The patient may receive other lipids to meet Essential Fatty Acid (EFA) and/or additional calorie needs. Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. If an adverse reaction is observed, IV steroids \& benadryl will be administered \& Omegaven will be discontinued. Patients will continue to receive infusions at CTCA for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home with Coram. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month (see Table 2).

Recruitment & Eligibility

Inclusion Criteria

Male or Female; ages 18 to 80 years old
Receiving treatment at Cancer Treatment Centers of America
Receiving PN (either in the infusion center or at home)
Have existing hepatic dysfunction defined as Elevation of > 3x the normal level of one or more of the following:Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), or Alanine Aminotransferase ALT) and/or Bilirubin > 2 mg/dl in the absence of biliary obstruction
Able to provide informed written consent

Exclusion Criteria

Hypertriglyceridemia (triglycerides [TG] > 400)
Allergy to fish or egg protein
Currently on therapeutic doses of Coumadin, heparin, or low molecular eight heparin
Hemodynamically unstable
Bilirubin > 5 mg/dL
Documented liver metastases
Unstable diabetes with known diabetic ketoacidosis within 7 days of screening
Recent cardiac infarction (within 6 months) and taking plavix
Severe hemorrhagic disorders
Current anticoagulation therapy for deep venous thromboembolism or pulmonary embolism
Active sepsis
Undefined coma status
In patients with abnormal kidney function, renal insufficiency with calculated creatinine clearance < 30 mL/min
Pregnancy or lactation

Arm && Interventions

Group	Intervention	Description
Omegaven (compassionate use)	Omegaven	This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Maximum Conjugated Bilirubin	Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.	Highest detected lab values will be summarized between baseline and end of study participation.
Average Improvement in ALT	Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.	Laboratory values will be summarized at baseline and as change from baseline to worst follow-up value
Average Change in Alkaline Phosphatase	Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.	lab values will be summarized at baseline and as change from baseline to worst follow-up value.
Number of Patients Experiencing Adverse Events	Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.	The number of patients reporting or experiencing adverse effects will be reported.
Average Improvement in AST	Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.	Lab values will be summarized at b aselin4e and as change from baseline to worst follow-up value.