RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase I-II Study HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer With or Without Metastatic Disease

Quick Facts

Study Start:2007-06

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01913106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 * PSA \> 10ng/ml within the past 3 months may enter study	* 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

Inclusion Criteria

Exclusion Criteria

* 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
* PSA \> 10ng/ml within the past 3 months may enter study

* 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

Contacts and Locations

Study Contact

Brent Bell, PA-C

CONTACT

713-394-1105

bcbell@houstonmethodist.org

Brian Butler, MD

CONTACT

ebutler@houstonmethodist.org

Principal Investigator

Edward B Butler, MD

PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Study Locations (Sites)

Houston Methodist

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

Edward B Butler, MD, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2007-06

Study Completion Date2028-12

Study Record Updates

Study Start Date2007-06

Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

Prostatic Neoplasms