Study of the Vascular Disrupting Agent NPI-2358 in Patients With Advanced Solid Tumors or Lymphoma

Inclusion criteria

• ECOG performance status ≤ 2
• Pathologically or histologically confirmed solid tumor malignancy
• Patients must not be candidates for regimens known to provide clinical benefit.
• All adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (v. 3.0) Grade ≤ 2, except for neurological toxicity that must have resolved to Grade ≤ 1.
• Adequate bone marrow reserve, hepatic and renal function
• Signed informed consent

Exclusion criteria

• Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 21 days prior to receipt of study medication (6 weeks for nitrosoureas or mitomycin C; 12 weeks for radioimmunotherapy). Major surgery, other than diagnostic surgery, within 6 weeks before first study drug administration. Radiotherapy within 4 weeks (some types of radiation therapy are excluded regardless of interval since treatment).
• Significant cardiac history or findings
• Underlying conditions or medications associated with bleeding diathesis
• Disorders associated with significant vascular pathology
• Lung cancer with central chest tumors
• Prior treatment with vascular disruptive agents
• Seizure disorder requiring anticonvulsant therapy; prior transient ischemic attack or cerebrovascular accident
• Brain metastases
• Severe chronic obstructive pulmonary disease (COPD) with hypoxemia
• Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy
• Known infection with human immunodeficiency virus (HIV), active hepatitis A, B, or C
• Patients with a prior hypersensitivity reaction to any product containing Solutol and/or propylene glycol
• Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use acceptable methods of birth control. Female patients with childbearing potential must have a negative serum pregnancy test. Male patients must be surgically sterile or agree to use an acceptable method of contraception.
• Concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix