| Inclusion Criteria: | 1) Male and female patients with histologically or cytologically confirmed diagnosis of cancer which is not amenable to curative therapy. For the purpose of this study, advanced disease will be defined as metastatic disease or locally advanced disease that is surgically unresectable and considered unmanageable with standard therapies such as radiation or systemic therapies.
2) Patients with advanced non-hematologic malignancies for whom no standard therapy exists.
3) Measurable disease by RECIST or evaluable disease (e.g., bone metastasis, pleural effusion, ascites, or lesions which do not fulfill RECIST criteria for metastatic disease)
4) Off all therapy (inclusive of investigational therapies) for at least 4 weeks prior to study drug administration OR off all daily or weekly therapy (inclusive of investigational therapies) for at least 2 weeks prior to study drug administration and without any side effects associated with these therapies.
5) Female patients of child-bearing potential must have a negative serum pregnancy test within 72 hours prior to first study drug administration and must agree to the use of a physical method of non-hormonal contraception while patient is participating in this study and at least 6 months following discontinuation of study drug.
6) Female patients who are postmenopausal must have 12 months of amenorrhea, surgically sterile, or must agree to the use of a physical method of non-hormonal contraception while patient is participating in this study and at least 6 months following discontinuation of study drug.
7) Male patients must be surgically sterile or agree to the use of a barrier method of contraception while patient is participating in this study and at least 6 months following discontinuation of study drug.
8) Life expectancy of >/= 3 months.
9) ECOG Performance Status of 0-1.
10) Patients must be able to provide informed consent indicating knowledge of his/her disease process, the investigational nature of the therapy, alternatives, benefits, and risks including potential side effects.
11) Age >/= 18 years of age.
12) No major surgery within 4 weeks before treatment with ABI-009. (A biopsy is not considered major surgery).
13) No chemotherapy, hormonal therapy, immunotherapy or radiotherapy within 4 weeks before treatment with ABI-009 (6 weeks for previous treatment with nitrosoureas, mitomycin, or extensive radiotherapy) and no immunosuppressive agents within 3 weeks before study entry (except corticosteroids used as antiemetics).
14) No immunosuppressive agents within 3 weeks before study entry (except corticosteroids used as antiemetics).
15) Required Initial Laboratory Data: Hemoglobin >/= 9.0 g/dL, WBC >/= 3,000/microliter, ANC >/= 1,500/microliter, Platelet count >/= 100,000/microliter, Total Bilirubin </= ULN, SGOT (AST) </= 1.5 x upper limits of normal, SGPT (ALT) </= 1.5 x upper limits of normal, Serum Cholesterol </= 350 mg/dL, Serum Triglyceride </= 300 mg/dL.
16) Adequate renal function with serum creatinine </= 1.5 mg/dL and/or creatinine clearance (Cockroft formula) >/= 60 mL/min.
17) No active alcohol abuse, drug addiction, or psychotic disorders.
18) No known concomitant genetic or acquired immunosuppressive diseases (such as AIDS).
19) If obese, a patient must be treated with doses calculated using his/her actual BSA (The physician must be comfortable treating at the full BSA dose regardless of BSA). |