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

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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Biological: CP-870,893

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of The University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Adverse Events	8 weeks

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: June 4, 2014
• First Submitted That Met QC Criteria: June 5, 2014
• First Posted (Estimate): June 6, 2014

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Subjects with Clinical Benefit After a Single Infusion of CP - 870, 893
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: UPCC 10904