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

NCT00095160

Last updated date
Study Location
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety Study of an Immune Response Modifier in Patients With Refractory Solid Organ Tumors
Official Title  ICMJE Phase I, Open Label Safety, Pharmacokinetic, and Pharmacodynamic Dose Escalation/De-escalation Study of 852A Administered Intravenously to Subjects With Refractory Solid Organ Tumors
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE Drug: 852A
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
42
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2006
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00095160
Other Study ID Numbers  ICMJE 2003LS039
1493-852A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey Miller, M.D., Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Jeffrey Miller, MDMasonic Cancer Center, University of Minnesota
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date November 2017

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