A Phase 1 Trial of ABI-011 in Patients With Advanced Solid Tumors or Lymphomas

Exclusion Criteria

• •Inability to comply with study and follow-up procedures
• •Women who are pregnant or lactating
• •Treatment with chemotherapy, hormonal therapy(except leuprolide for prostate cancer), immunotherapy, biologic therapy, or radiation therapy as cancer therapy within 4 weeks before initiation of study treatment. Six weeks should have elapsed if prior chemotherapy treatment included nitrosoureas or mitomycin C
• •Pts. who have received antibody-based therapies within 28 days or 5 half-lives of the agent, whichever time period is longer
• •Major surgery within 6 weeks before first study drug administration
• •Prior treatment with tumor vascular disruptive agents
• •Any uncontrolled medical or psychiatric risk factors
• •Central nervous system(CNS)metastases.
• •History of diabetic retinopathy. All patients must be evaluated by an ophthalmologist prior to study treatment
• •Any history of myopathy, either peripheral or cardiac
• •Current use of medications that may have the potential of QTc prolongation
• •History of allergy or hypersensitivity to any compound of the ABI-011 formulation
• •Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
• •Pt.has known infection with human immunodeficiency virus (HIV),or known chronic Hepatitis B or Hepatitis C
• •Inability to be venipunctured and/or tolerate venous access
• •History of other carcinoma within past 5 years
• •Pts. requiring therapeutic anticoagulation with either coumadin or low molecular weight heparin or with history of any bleeding diathesis. Low dose aspirin and low dose coumadin for catheter maintenance are allowed
• •Lung tumors in a central position.
• •* Left ventricular ejection fraction (LVEF)\< 50% by echocardiography;
• •* Previous history of MI or ischemic heart disease
• •* EKG findings suggestive of current or previous ischemic heart disease, including left bundle branch block
• •* Prior treatment with chemotherapy agents known to potentially cause cardiotoxicity
• •* Class III or IV heart failure as defined by the New York Heart(NYHA) functional classification
• •* Congenital or acquired long QT syndrome
• •* Uncontrolled hypertension
• •* Current or past history of clinically significant arrhythmias
• •* QTc prolongation
• •* HO Symptomatic PVD (Venous or arterial)
• •Seizure disease requiring current anticonvulsant treatment
• •HO previous CVA or TIA
• •HO inflammatory bowel disease (active or past) or active PUD
• •HO previous, whole abdomen radiation therapy or more than Grade 1 residual toxicity from previous radiation therapy.
• •History of autoimmune disease or vascular disease (venous or arterial)