Prostatic Neoplasms Clinical Trial
Official title:
Phase I-II Study HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer With or Without Metastatic Disease
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 2028 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Houston Methodist | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The Methodist Hospital System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1. Safety based on standard laboratory and clinical adverse event monitoring | 5-year biochemical disease free survival rate | Yes | |
Secondary | Local control survival (measured by PSA and biopsy) | 5-year biochemical disease free survival rate | Yes | |
Secondary | Evaluate immunological markers | 5-year post treatment | Yes |
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