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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Cancer, Hepatic Injury

Intervention / Treatment
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* Drug: Omegaven


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omegaven (compassionate use)<br>This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks. | Drug: Omegaven<br>* 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. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). 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. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month.<br>* Other names: fish oil;|

What is the study measuring?
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Primary Outcome Measures

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