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.