Status:
RECRUITING
HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer
Lead Sponsor:
The Methodist Hospital Research Institute
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
This investigational new drug application describes a proposed phase I/II study designed to assess the safety and efficacy of AdV-tk gene therapy in combination with standard brachytherapy for patient...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01913106
Start Date
June 1 2007
End Date
December 1 2028
Last Update
July 1 2016
Active Locations (1)
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1
Houston Methodist
Houston, Texas, United States, 77030