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

Study Overview
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Brief Summary
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Patients who had clinical benefit following a single infusion of CP-870, 893 on Protocol UPCC 10903 will receive a single repeated infusion of CP-870,893 at the same dose given on UPCC 10903 intravenously.

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

Conditions
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Solid Tumors

Intervention / Treatment
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* Biological: CP-870,893


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects from UPCC 10903<br> | Biological: CP-870,893<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subjects with Clinical Benefit After a Single Infusion of CP - 870, 893