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
Early Phase 1
Completed
- Conditions
- Solid Tumors
- Interventions
- Biological: CP-870,893
- Registration Number
- NCT02157831
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Subjects from UPCC 10903 CP-870,893 -
- Primary Outcome Measures
Name Time Method Number of Adverse Events 8 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States