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Safety Study of an Immune Response Modifier in Patients With Refractory Solid Organ Tumors
This study has been completed.
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00095160
  Purpose

Study 1493-852A is a phase 1 study with the primary objective of determining safety and the highest tolerated dose of an experimental immune response modifier administered intravenously to patients with solid organ tumors not responsive to currently available treatments. The secondary objective of the study is to monitor the tumor response to this form of treatment.


Condition Intervention Phase
Neoplasms
Drug: 852A
Phase I

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and Pharmacokinetics

Secondary Outcome Measures:
  • Tumor Response

Estimated Enrollment: 42
Study Start Date: October 2003
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have solid organ tumors refractory to currently available treatments.
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
  • Have a life expectancy of 4 months
  • Have normal organ and bone marrow function

Exclusion Criteria:

  • Have had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy within 4 weeks prior to the 1st dose of the study drug or those who have not recovered from adverse events from agents administered more than 4 weeks earlier.
  • Use of investigational agent in the 4 weeks prior to 1st dose of the study drug
  • Use of immunosuppressive therapy in the 4 weeks prior to the 1st dose
  • Have a history of, or clinical evidence of, myocardial ischemia, congestive heart failure, or myocardial arrhythmias requiring treatment within the past 6 months
  • Have uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis B or C, immune dysfunction such as autoimmune disease, endocrine dysfunction such as hypo- or hyperthyroidism, psychiatric illness such as depression or suicidal tendency or social situations that would limit compliance with study requirements
  • Have a history of disease requiring ongoing steroid treatment
  • Have a history of seizure disorders uncontrolled on medication
  • Have a history of clinically significant coagulation or bleeding disorders or abnormalities
  • Are HIV positive. HIV positive subjects are excluded from the study because of possible interactions with the immunomodulatory effects of 852A and because of potential pharmacokinetic interactions associated with combination retroviral therapy.
  • Are pregnant or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095160

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States
Sponsors and Collaborators
Pfizer
  More Information

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: 1493-852A
Study First Received: November 1, 2004
Last Updated: October 24, 2008
ClinicalTrials.gov Identifier: NCT00095160  
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Solid Organ Tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009