ABI-009 Trial in Patients With Advanced Non-hematologic Malignancies

Inclusion Criteria

• •Each subject must meet the following criteria to be enrolled in this study.
• •1. Male and female patients with histologically or cytologically confirmed diagnosis of cancer which is not amenable to curative therapy.
• •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 7 days prior to first study drug administration.
• •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.
• •7. Male patients must be surgically sterile or agree to the use of a barrier method of contraception.
• •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/µl
• •* ANC ≥ 1,500/µl
• •* Platelet count ≥ 100,000/µl
• •* Total Bilirubin ≤ ULN
• •* SGOT (AST) SGPT (ALT) ≤ 1.5 x ULN ≤ 1.5 x ULN
• •* 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).