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

Conditions

Prostatic Neoplasms

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Prostatic Neoplasms
Intervention / Treatment

-

Contacts and Locations

Houston

Houston Methodist, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Methodist Hospital Research Institute,

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

Study Record Dates

2028-12