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

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.

Eligibility

INCLUSION 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

EXCLUSION CRITERIA:

* 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

Conditions2

Locations1 site

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