Study of Liposome Encapsulated Mitoxantrone (LEM) in Patients With Advanced Cancer

You may be eligible if

• Disease Characteristics-
• Advanced (local and/or metastatic) histologically documented solid tumors
• Disease is not considered responsive to available conventional modalities or treatments
• Prior/Concurrent Therapy-
• Must be fully recovered from acute toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline before most recent treatment)
• No radiotherapy, treatment with cytotoxic or biologic agents within 3 weeks prior to study entry (6 weeks for mitomycin or nitrosoureas)
• At least 2 weeks after any prior surgery or hormonal therapy
• Chronic toxicities of grade 1 from prior treatment are permitted
• Patient Characteristics-
• 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 10 g/dL; albumin at least 3.0 mg/dL; Serum creatinine at least 2.0 mg/dL; Total bilirubin not more than upper limit of normal; ALT, AST, and alkaline phosphatase not more than 1.5 x upper limit of normal; LVEF by MUGA scan greater than or equal to the lower limit of normal
• Must sign informed consent
• No pregnant and/or nursing 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 use acceptable contraceptive methods.
• No active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease)
• No active infection of any kind
• No known HIV infection or viral hepatitis
• No active heart disease including myocardial infarction within the previous 6 months, symptomatic coronary artery disease, arrhythmias requiring medication, or congestive heart failure
• No known CNS metastases
• No patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication
• No patients requiring immediate palliative treatment of any kind including surgery
• No patients who have received a high-dose chemotherapy regimen with stem cell support in the previous 6 months
• No patients who have received a cumulative anthracycline dose greater than 250 mg/m2 (doxorubicin equivalent)
• No patients unwilling or unable to follow protocol requirements
• No patients with known hypersensitivity to mitoxantrone or liposomes.