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

Conditions: Solid Tumors

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.


Eligibility criteria:
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.

Keywords: subjects with clinical benefit after a single infusion of cp - 870, 893