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Safety Study of an Immune Response Modifier in Patients With Refractory Solid Organ Tumors
Basic Trial Information Trial Description Summary Eligibility Criteria Trial Contact Information
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase I | Treatment | Completed | 18 and over | 1493-852A NCT00095160 |
Trial Description
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. Eligibility 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
Trial Contact Information
Trial Lead Organizations/Sponsors Pfizer Incorporated Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00095160 Information obtained from ClinicalTrials.gov on March 18, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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