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Safety Study of an Immune Response Modifier in Patients With Refractory Solid Organ Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00095160
First Posted: November 2, 2004
Last Update Posted: November 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by:
Masonic Cancer Center, University of Minnesota
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I, Open Label Safety, Pharmacokinetic, and Pharmacodynamic Dose Escalation/De-escalation Study of 852A Administered Intravenously to Subjects With Refractory Solid Organ Tumors

Further study details as provided by Masonic Cancer Center, University of Minnesota:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095160


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Pfizer
Investigators
Principal Investigator: Jeffrey Miller, MD Masonic Cancer Center, University of Minnesota
  More Information

Responsible Party: Jeffrey Miller, M.D., Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00095160     History of Changes
Other Study ID Numbers: 2003LS039
1493-852A
First Submitted: November 1, 2004
First Posted: November 2, 2004
Last Update Posted: November 29, 2017
Last Verified: November 2017

Keywords provided by Masonic Cancer Center, University of Minnesota:
Solid Organ Tumors