Solid Tumors
Conditions
Keywords
Subjects with Clinical Benefit After a Single Infusion of CP - 870, 893
Brief summary
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.
Interventions
BIOLOGICALCP-870,893
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Adverse Events | 8 weeks |
Countries
United States
Outcome results
None listed