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CompletedNCT00095160Updated Nov 29, 2017

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

A Phase 1 interventional study of 852A in Neoplasms, sponsored by Masonic Cancer Center, University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-29.

Sponsored by Masonic Cancer Center, University of Minnesota · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Neoplasms

Keywords

  • Solid Organ Tumors
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In context

Lead sponsor

Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants

Interventions

  • Drug852A
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What researchers measure

Primary outcomes

  1. Safety and Pharmacokinetics

Secondary outcomes

  1. Tumor Response

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Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00095160
Lead sponsor
Masonic Cancer Center, University of Minnesota
Collaborators
Pfizer
First posted
Nov 2, 2004
Start date
Oct 2003
Primary completion
Jan 2006
Completion
Jan 2006
Last update
Nov 29, 2017

Study contacts

Jeffrey Miller, MD
principal investigator · Masonic Cancer Center, University of Minnesota
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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