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.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: 852A

• Study Type: Interventional
• Enrollment: 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety and Pharmacokinetics

Secondary Outcome Measures

Outcome Measure
Tumor Response

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborators: Pfizer
• Investigators: Principal Investigator: Jeffrey Miller, MD, Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Primary Completion (Actual): January 1, 2006
• Study Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: November 1, 2004
• First Submitted That Met QC Criteria: November 1, 2004
• First Posted (Estimate): November 2, 2004

Study Record Updates

• Last Update Posted (Actual): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Solid Organ Tumors
• Other Study ID Numbers: 2003LS039; 1493-852A