HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer
Phase I-II Study HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer With or Without Metastatic Disease
About This Trial
- This clinical trial is testing a combination of an experimental gene therapy, an antiviral pill, and internal radiation to treat prostate cancer that has returned.
- It is designed for men whose cancer has come back locally in the prostate after prior radiation and hormone therapy, but has not spread to other parts of the body.
- During the study, doctors place radiation directly into the prostate alongside a specialized gene injection and an antiviral medicine.
- Before considering this trial, patients should know they must be in generally good overall health, have a prostate below a certain size, and have no allergies to antiviral medications.
More Information
- 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.
Who Can Enroll
- Gender: Male
- Who This Trial is For: This clinical trial is testing a combination of an experimental gene therapy, an antiviral pill, and internal radiation to treat prostate cancer that has returned.
Study Details
- Start Date: June 2007
- Lead Sponsor: The Methodist Hospital Research Institute
Full Eligibility Criteria
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 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
Treatments
- Drug: HSV-tk +Valacyclovir in Combination with Brachytherapy