Gene Therapy for Prostate Cancer That Returns After Radiation Therapy
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 10/19/2013 |
| Start Date: | April 2005 |
| End Date: | April 2006 |
Phase I Trial of Adenovirus- Mediated IL-12 Gene Transduction in Patients With Radiorecurrent Prostate Cancer
The purpose of this research study is to test a new treatment for prostate cancer. We have
been exploring the use of cytokine (immune stimulating) gene therapy by directly injecting a
virus which produces a cytokine called interleukin-12 (IL-12) into the prostate gland to
control tumor growth. We propose to explore the use of adenovirus-mediated human
interleukin-12 (Ad.hIL-12) in patients with recurrent non-metastatic prostate cancer
following radiation therapy in a Phase I trial. Participants will be placed in rising dose
groups with the primary endpoint of learning the maximum dose that can safely be given by
injection directly into the prostate gland. Toxicity will be determined through physical
examination, laboratory values, and blood levels of cytokines. Evidence of an immune
response against prostate proteins will also be monitored. If the treatment works, the
cancer will shrink or not grow. This will be monitored by prostate specific antigen (PSA)
levels in the blood. However, we do not know if this treatment will be effective. If the PSA
continues to rise after treatment, participants will be taken off study and offered other
treatment. There is no compensation for participation in this research study. There will be
no charge for the treatment with gene therapy or the monitoring associated with this
research study. Monitoring will occur in a specially designated clinical research center.
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
weeks
- 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
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