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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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 more

Other 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor

300 Previous Clinical Trials

2,099,984 Total Patients Enrolled

3 Trials studying Prostate Cancer

103 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for participants in this research endeavor?

"Unfortunately, this particular research endeavour has ended its recruitment period. Initially posted on August 1st 2015 and last updated on February 17th 2022, the initiative is no longer accepting new participants; however, there are a considerable amount of other trials actively searching for volunteers at present."

Answered by AI

What safety measures have been taken to ensure the protection of patients using Ad5-yCD/mutTKSR39rep-hIL12?

"Our team at Power has judged the safety of Ad5-yCD/mutTKSR39rep-hIL12 to be a 1, due to it being an early stage trial with limited data on both efficacy and security."

Answered by AI

Recent research and studies

Gene TherapyJournal

Efficacy of Oncolytic Adenovirus Expressing Suicide Genes and Interleukin-12 in Preclinical Model of Prostate Cancer

Freytag, S O, K N Barton, and Y Zhang. 2013. “Efficacy of Oncolytic Adenovirus Expressing Suicide Genes and Interleukin-12 in Preclinical Model of Prostate Cancer”. Gene Therapy. Springer Science and Business Media LLC. doi:10.1038/gt.2013.40.

clinicaltrials.govStudy

Phase 1 Trial of Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer

Farzan Siddiqui 2015. "Phase 1 Trial of Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02555397.

All > Recurrent Prostate Cancer