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Virus Therapy
Ad5-yCD/mutTKSR39rep-hIL12 for Prostate Cancer
Phase 1
Waitlist Available
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that uses a virus to kill cancer cells. They want to find out what dose is safe and effective.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-dependent toxicity and maximum tolerated dose (MTD) of adenovirus
Secondary outcome measures
Disease-specific and overall survival
Freedom from biochemical/clinical failure (FFF)
PSA doubling time (PSADT)
+2 moreOther outcome measures
Association between the primary and and immunological endpoints including serum IL-12 and IFN-y levels and NK cell cytolytic activity
Trial Design
1Treatment groups
Experimental Treatment
Group I: SingleExperimental Treatment1 Intervention
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 to 1 x 10e12 viral particles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ad5-yCD/mutTKSR39rep-hIL12
2017
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Henry Ford Health SystemLead Sponsor
304 Previous Clinical Trials
2,104,417 Total Patients Enrolled
3 Trials studying Prostate Cancer
103 Patients Enrolled for Prostate Cancer
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