Redosing With CP-870, 893 in Patients With Clinical Benefit After a Single Infusion From A Phase I, Open-Label, Dose-Escalation Study of CP-870,893 in Patients With Solid Tumors

Exclusion Criteria

• •Concurrent treatment with any anticancer agent;
• •History of autoimmune disorder, including pemphigus vulgaris, systemic mastocytosis, systemic lupus erythamatosus, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen's syndrome, vasculitis/arteritis, Behcet's syndrome, inflammatory bowel disease, autoimmune thyroiditis, multiple sclerosis, or other chronic inflammatory disease;
• •Treatment with any other cancer therapy from the time of the first dose of CP-870,893, except as noted in Section 4.4; 1 Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 3.0, DCTD, NCI, NIH, DHHS. 31 Mar 2003 (http://ctep.cancer.gov).
• •History of congestive heart failure, stroke, or myocardial infarction;
• •Hereditary or acquired coagulopathies (e.g. hemophilia, von Willebrand's disease, cancer-associated DIC);
• •Brain metastases.
• •Patient having reproductive potential who is not using an effective method of birth control or who is pregnant or breastfeeding or has a positive (urine or serum) pregnancy test at baseline;
• •Known sensitivity to immunomodulating agents or monoclonal antibodies;
• •Alcohol abuse or illicit drug use within 12 months of enrollment;
• •History of serum creatinine ≥2 mg/dL for any duration and for any reason;
• •Urine dipstick 1+ or more positive for blood (other than menstruating females) or 2+ or more positive for protein;
• •Positive HAHA antibody titer in response to treatment with first dose of CP-870,893 (as determined by Pfizer)
• •Clinically significant presence of granular or cellular casts in centrifuged urine sediment;
• •Renal carcinoma or renal metastases;
• •Partial or complete nephrectomy;
• •History of dialysis (peritoneal or hemodialysis);
• •Prior treatment with Amphotericin B or cisplatin;
• •History of insulin-dependent diabetes for greater than 5 years;
• •Concomitant treatment with systemic corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline;
• •Concomitant treatment with anticoagulants, such as coumadin or heparin, except to maintain patency of in-dwelling catheters;
• •Prior allergic reactions attributed to compounds of similar chemical or biologic composition to study drug (e.g., rituximab or immunoglobulin G);
• •Ongoing or active infection;
• •Required the use of systemic antibiotics or antifungals for ongoing or recurrent infections. Topical use of antibiotics or antifungals is allowed;
• •Other uncontrolled concurrent illness that would preclude study participation; or Psychiatric illness or social situation that would preclude study participation.