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Phase I Trial of Adenovirus- Mediated IL-12 Gene Transduction in Patients With Radiorecurrent Prostate Cancer

Phase 1
40 Years
75 Years
Open (Enrolling)
Prostatic Neoplasms, Neoplasm Recurrence, Local

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Trial Information

Phase I Trial of Adenovirus- Mediated IL-12 Gene Transduction in Patients With Radiorecurrent Prostate Cancer

Patients with radiorecurrent prostate cancer have few viable treatment options, both in
terms of efficacy and morbidity. Local therapies fail even in highly selected patients due
to locally advanced disease, microscopic metastases, and a worsening of the biology of
cancer cells. Furthermore, attempts at salvage local treatments have the complications of
incontinence, impotence and in some cases unremitting penile pain. Pre-clinical studies in a
mouse model of prostate cancer have noted the potential benefit of adenovirus-mediated gene
therapy to deliver IL-12 in this clinical scenario. This treatment was able to significantly
growth suppress the injected tumor to prolong survival and reduce the number of
pre-established metastases. The mechanisms underlying this activity involved both innate
immunity (neutrophils and natural killer [NK] cells) and acquired immunity ( T cells) and
enhanced expression of Fas to further sensitize Fas/Fas ligand (FasL) killing.

This is a Phase I study. Therefore, the primary objective is finding the Maximum Tolerated
Dose. Within this realm will be monitoring of pro-inflammatory cytokines. Secondary aspects
will involve correlating important mechanisms identified in the pre-clinical model:
induction of T cells.

Inclusion Criteria:

- A local recurrence of prostate cancer (in or next to gland) following treatment by
radiation therapy (either external beam or seed implantation)

- Rising PSA (Prostate Specific Antigen) on at least three occasions separated by two

- Ultrasound guided biopsy to diagnose recurrent disease within the prostate

- No evidence of prostate cancer that has spread on bone scan or Computed Tomography
(CT) scan

- No hormone therapy at time of enrollment to the research study

Exclusion Criteria:

- Radical prostatectomy for treatment of prostate cancer

- Detectable spread of prostate cancer on bone or CT scan

- Immunosuppressive medication within two months of the study

- Acute infection (any bacterial, viral, fungal infection requiring specific therapy)

- HIV disease

- Other significant medical or psychiatric conditions which pose high risk for an
investigational study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To study in a Phase I clinical trial the safety of intraprostatic injection of a replication incompetent adenovirus expressing hIL-12 in patients with radiorecurrent prostate cancer


United States: Food and Drug Administration

Study ID:

GCO # 01-0595



Start Date:

April 2005

Completion Date:

April 2006

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasm Recurrence, Local
  • Prostate Cancer
  • Radiation Therapy
  • Local recurrence
  • Gene Therapy
  • Neoplasms
  • Neoplasm Recurrence, Local
  • Prostatic Neoplasms
  • Recurrence



Mount Sinai School of Medicine New York, New York  10029