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

Recruiting now · Phase 1/Phase 2

Conditions studied: Prostatic Neoplasms

In brief

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 facts

Study ID

NCT01913106

Run by

The Methodist Hospital Research Institute

People needed

25

Starts

2007-06-01

Expected to finish

2028-12-01

Last updated by the study team

2016-07-01

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

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

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

Where it is running

• Houston Methodist — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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