HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT01913106
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • HSV-tk +Valacyclovir in Combination with Brachytherapy — DRUG
    The investigators insert a gene from a herpes simplex virus (HSV), which is a small piece of the basic structure of the virus, into the prostate gland tumor cells. The gene is called the thymidine kinase (tk) gene, which the cell uses to make a protein that can change valacyclovir, The way the tk gene will be transported into the tumor cells is by using a vector or "vehicle" to carry the tk gene into the cells. In this case the vector is a virus - an adenovirus. Scientists at the Department of Cell and Gene Therapy at The Methodist Hospital removed a portion of the adenovirus' genetic material that allows it to replicate so that it cannot cause infections. In place of the removed genetic material the scientists inserted the tk gene. Now the vector can carry the tk gene into tumor cells. When the vector/gene combination gets into tumor cells, it inserts itself into the cells' command center (nucleus) and tells the tumor cells to begin making thymidine kinase protein.

Study Details

The purpose of this study is to conduct a Phase I - II clinical trial to extend preclinical studies involving in situ HSV-tk + Valacyclovir gene therapy in combination with brachytherapy for recurrent prostate cancer. This will provide a novel therapeutic approach to prostate cancer and hopefully impact on the development of metastatic disease and the control of preexisting metastasis.

Key Dates

Start date
Jun 30, 2007
Status verified
Jun 2016
Primary completion
Dec 31, 2018
Completion
Dec 31, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HSV-tk + Valacyclovir and Brachytherapy
    You will be given an antibiotic (Ciproflaxin) to take twice a day beginning the day before the procedure, and continuing for a total of 3 - 5 days. You will also be given 4 pills called (Valtrex) valacyclovir to take three times a day for 14 days, beginning the day before the procedure. You will be given a pill diary in which you will record each dose of valacyclovir that you take. You will receive brachytherapy (radioactive seed placement) the day after you begin taking your pills. After the radioactive seeds are placed, while you are still in the operating room, you will receive an injection into your prostate of 1 or 2 ml (one-fifth or two-fifths of a teaspoon) of a solution of the vector carrying the gene.

Primary Outcome Measure

1. Safety based on standard laboratory and clinical adverse event monitoring [ Time Frame: 5-year biochemical disease free survival rate ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston MethodistHoustonTexas77030
Brent Bell, PA-C
[email protected]
713-394-1105
Edward B Butler, MD
[email protected]
Edward B Butler, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Houston Methodist· Houston, TX

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