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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00095160
First received: November 1, 2004
Last updated: October 6, 2009
Last verified: October 2009

November 1, 2004
October 6, 2009
October 2003
January 2006   (final data collection date for primary outcome measure)
Safety and Pharmacokinetics
Same as current
Complete list of historical versions of study NCT00095160 on ClinicalTrials.gov Archive Site
Tumor Response
Same as current
Not Provided
Not Provided
 
Safety Study of an Immune Response Modifier in Patients With Refractory Solid Organ Tumors
Phase I, Open Label Safety, Pharmacokinetic, and Pharmacodynamic Dose Escalation/De-escalation Study of 852A Administered Intravenously to Subjects With Refractory Solid Organ Tumors

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
Drug: 852A
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
January 2006
January 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00095160
2003LS039, 1493-852A
Not Provided
Jeffrey Miller, M.D., Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
Pfizer
Principal Investigator: Jeffrey Miller, MD Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP