HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer
About this study
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.
- Condition
- Prostatic Neoplasms
- Tested
- HSV-tk +Valacyclovir in Combination with Brachytherapy
- Sponsor
- The Methodist Hospital Research Institute
Who can join
- Age
- Not specified
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 18
- Eligible sex: Male
- Study condition: Prostatic Neoplasms
- 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 11
- 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
1 site, 1 recruiting
Houston Methodist
Houston, Texas, United States
Contact
-
Brent Bell, PA-C
713-394-1105 bcbell@houstonmethodist.org
-
Brian Butler, MD
Potential match only. Final eligibility is determined by the study team.