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

Inclusion criteria

• Clinical benefit, including stable disease, partial response, or complete response, without a dose-limiting toxicity after a single infusion of CP-870,893; however, patients who experienced transient, not serious, and fully reversible grade 1-3 increases in ALT or AST after one dose of CP-870,893 may, if otherwise eligible, receive a second dose on this protocol.
• Age at least 18 years old;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1;
• Adequate bone marrow function documented within 2 weeks prior to treatment, defined as:
• White blood cell (WBC) count >3000 cells/μL without growth factor support;
• Absolute neutrophil count (ANC) ≥1500/μL without growth factor support;
• Platelets >100,000/μL without growth factor support; and
• Hemoglobin ≥10 g/dL.
• Adequate renal and hepatic function documented within 2 weeks prior to treatment, defined as:
• Total bilirubin <1.5 times the upper limit of normal (ULN);
• Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <2.5 × ULN;
• Creatinine clearance (CLcr, measured or calculated) >80 mL/min; and
• Life expectancy of at least 12 weeks;
• Signed written informed consent.

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.