Liposome Encapsulated SN38 (LE-SN38) in Patients With Advanced Cancer

You may be eligible if

• Disease Characteristics:
• Advanced (local and/or metastatic) histologically documented solid tumors
• Disease not considered responsive to available conventional modalities or treatments
• No life prolonging therapy or therapy with a greater potential for patient benefit is available
• Prior/Concurrent Therapy:
• No treatment with cytotoxic or biologic agents within 3 weeks prior to study entry (6 weeks for radiotherapy, mitomycin and nitrosoureas)
• At least 2 weeks since any prior surgery or hematopoietic growth factor therapy
• Chronic Grade 1 toxicities due to prior treatment or other causes are permitted
• Patient Characteristics:
• Must have ECOG Performance status of 0-2
• Must be at least 18 years of age
• Must have the following clinical laboratory values: ANC at least 1,500/mm3, platelets at least 100,000/mm3, hemoglobin at least 9 g/dL, albumin at least 3.0 g/dL, serum creatinine not more than 2.0 mg/dL, total bilirubin not more than the institutional upper limit of normal, alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase not more than 1.5 x the institutional upper limit of normal
• Must sign informed consent
• No active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease)
• No infection requiring parenteral antibiotics
• No known HIV infection or viral hepatitis
• No active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, arrhythmias requiring medication
• No known or suspected active CNS metastasis
• No pregnant or nursing female patients. Women of child-bearing potential must have negative serum or urine pregnancy test within 1 week prior to study entry. Sexually active patients (both men and women) must agree to use acceptable contraceptive methods, e.g., double barrier, during the conduct of the study
• No agent which could interfere with SN38 metabolism, including phenobarbital, valproic acid, cyclosporine or phenytoin
• No concurrent treatment for cancer or any other investigational agent for any indication within 30 days prior to receiving the first dose of study drug
• No immediate palliative treatment of any kind including surgery
• No high-dose chemotherapy regimen with stem cell support in the previous 6 months
• No abdominal or pelvic radiation therapy
• Not willing or unable to follow protocol requirements
• No known hypersensitivity to irinotecan, SN38, or liposomes