Status:
COMPLETED
Vector Delivery of the IL-12 Gene in Men With Prostate Cancer
Lead Sponsor:
Baylor College of Medicine
Conditions:
Prostatic Neoplasms
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This study is designed to determine the safety of IL-12 gene therapy for patients with recurrence of prostate cancer after radiation therapy and those with or without metastatic disease with a prostat...
Detailed Description
The development of a clinical trial for gene therapy in prostate cancer will be coordinated with our collaborators at Baylor involved in similar studies in order to facilitate the approval process. We...
Eligibility Criteria
Inclusion
- Men who have biopsy-proven local recurrence or persistence of cancer in the prostate gland with or without metastatic disease after the hormone therapy, cryosurgery, and/or the completion of definitive radiation therapy for at least one year.
- Patients must have evidence of biologically active local recurrence of tumor as demonstrated by a rising serum PSA level on at least 3 separate occasions at least 2 weeks apart, and that the serum PSA be below 50 ng/ml.
- The patient will possess the ability to give informed consent and express a willingness to meet all the expected requirements of the protocol for the duration of the study. (Informed Consent Document).
- Patients must have adequate baseline organ function as assessed by the following laboratory values before initiating the protocol.
- Adequate renal function with serum creatinine less than 1.5 mg/dl or creatinine clearance greater than 45 ml/min/m2.
- Platelet count greater than 100,000 platelets/mm3.
- Absolute neutrophil count greater than 1000/mm3.
- Hemoglobin greater than 8.5 mg/dl
- Normal partial thromboplastin time (PTT) and Pro-Thrombin Time (PT).
- Bilirubin less than 2.5 mg/dl, SGOT and SGPT less than 2.0x normal.
Exclusion
- Acute infection: Acute infection is defined as any viral, bacterial or fungal infection, which requires specific therapy.
- Symptomatic metastasis.
- Metastatic lesions in the CNS/spinal cord or organs that could become life or function threatening within 3 months.
Key Trial Info
Start Date :
June 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00406939
Start Date
June 1 1998
End Date
December 1 2007
Last Update
July 10 2008
Active Locations (1)
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1
Baylor College of Medicine Scott Department of Urology
Houston, Texas, United States, 77030