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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157831
• Other study ID #: UPCC 10904
• Status: Completed
• Phase: Early Phase 1
• Start date: July 2005
• Est. completion date: February 2008

Study information

• Verified date: August 2018
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Biological:
• CP-870,893

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		8 weeks