Vector Delivery of the IL-12 Gene in Men With Prostate Cancer

Completed · Phase 1

Conditions studied: Prostatic Neoplasms, Prostate Cancer

In brief

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 prostate gland intact. These, of course, would include recurrent prostate cancer after definitive radiation therapy. The prostate cancer will be treated with a prostatic injection of a replication-defective adenovirus vector delivering the IL-12 gene. Following virus injection, patients will be hospitalized for 23 hours for observation. Only one course of therapy will be administered. Each patient will be carefully monitored for toxic effects. Three to five patients will be tested with a low dose of virus and if there are no serious adverse side effects, the dose will be slowly escalated in subsequent groups of 3-5 patients or until unacceptable toxicity is reached. Effectiveness will be monitored by serum prostate-specific antigen (PSA), transrectal ultrasound of the prostate, prostate biopsy and comparison of survival times to historical survival times for patients with radiation recurrent prostate tumors. The primary objective of this initial study is to determine whether the treatment is associated with significant toxicity.

Key facts

Study ID

NCT00406939

Run by

Baylor College of Medicine

People needed

4

Starts

1998-06-01

Expected to finish

2007-12-01

Last updated by the study team

2008-07-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Baylor College of Medicine Scott Department of Urology — Houston, Texas, United States

Full record on ClinicalTrials.gov

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