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

NCT01913106 | Recruiting Phase 1 DMC

• 2 other identifiers: Pro00000601IRB 0107-0009
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• 1. Safety based on standard laboratory and clinical adverse event monitoring

  5-year biochemical disease free survival rate

Secondary Outcomes (2)

• Local control survival (measured by PSA and biopsy)

  5-year biochemical disease free survival rate

• Evaluate immunological markers

  5-year post treatment

Study Arms (1)

HSV-tk + Valacyclovir and Brachytherapy

EXPERIMENTAL

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.

Drug: HSV-tk +Valacyclovir in Combination with Brachytherapy

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.

Also known as: IND 13567

HSV-tk + Valacyclovir and Brachytherapy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• biopsy-proven local recurrence of prostate cancer without metastatic disease after the hormone therapy at least 2 year after the completion of definitive radiation therapy
• Zubrod performance status 0-1
• WBC ≥ 4,000/μl, platelets ≥ 100,000/μl
• hemoglobin ≥ 8.5 mg/dl
• normal partial thromboplastin time and prothrombin time
• bilirubin \< 1.5 mg/dl, and AST and alanine aminotransferase \< 2.5 times the upper limit of normal
• Serum creatinine ≤ 1.6 mg/dl
• Must undergo pre-treatment evaluation of tumor extent and tumor measurement
• Nutritional and general physical condition must be considered compatible with the proposed radio-therapeutic treatment
• Not on any other experimental therapeutic cancer treatment
• No active untreated infection
• No major medical or psychiatric illness
• International Prostate Symptom Score (IPSS) less than 15
• Signed study-specific consent form prior to study entry
• Prostate volume less than 50 cc

You may not qualify if:

• Symptomatic metastasis disease
• Patients with a life expectancy \< 10 years
• Patients on corticosteroids or any immunosuppressive drugs.
• HIV + patients
• Patients with acute infections (viral, bacterial, or fungal infections requiring therapy)
• Patients with cirrhosis.
• Patients with collagen vascular diseases
• International Prostate Symptom Score (IPSS) greater than 15
• Prostate volume greater than 50 cc
• Second active cancer except cutaneous cancer
• Patients with history of allergies to valacyclovir, acyclovier or who cannot take oral pills

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Edward B Butler, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brent Bell, PA-C

CONTACT

713-394-1105; bcbell@houstonmethodist.org

Brian Butler, MD

CONTACT

ebutler@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: July 31, 2013
• Study Start: June 1, 2007
• Primary Completion: December 1, 2018
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 1, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)