Expired Study
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Minneapolis, Minnesota 55455


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.


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


Study is Available At:


Original ID:

2003LS039


NCT ID:

NCT00095160


Secondary ID:

1493-852A


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Masonic Cancer Center, University of Minnesota


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

42


Enrollment Type:


Overall Contact Information

Official Name:Jeffrey Miller, MD
Principal Investigator
Masonic Cancer Center, University of Minnesota

Study Dates

Start Date:October 2003
Completion Date:January 2006
Completion Type:Actual
Primary Completion Date:January 2006
Primary Completion Type:Actual
Verification Date:November 2017
Last Changed Date:November 27, 2017
First Received Date:November 1, 2004

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Tumor Response
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Safety and Pharmacokinetics
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:852A

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Masonic Cancer Center, University of Minnesota
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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