Phase 1 Trial of Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer

Inclusion Criteria:

- Biopsy-proven local recurrence of prostate cancer at least one year after the
completion of definitive radiation therapy

- Evidence of biologically active disease as demonstrated by an unequivocally rising
serum PSA level that is ≥ 2 ng/mL above the nadir

- PSA < 100 ng/mL

- Age ≥ 18 years

- Karnofsky performance status ≥ 70

- Negative lymph nondes as established by imaging (pelvic CT or pelvic MRI)

- No evidence of metastatic disease, as evaluated by bone scan and CT scan of the
abdomen and pelvis.

- Subjects must have adequate baseline organ function as assessed by the the following
laboratory values:

- Adequate renal function with serum creatinine ≤ 1.5 mg/dL

- Platelet count > 100,000/µL

- Absolute neutrophil count > 1,000/µL

- Hemoglobin > 10.0 g/dL

- Bilirubin > 1.5 mg/dL

- AST/SGOT and ALT/SGPT < 3.0 times upper limit of normal (ULN)

- Men of child-producing potential must be willing to consent to use effective
contraception for at least 3 months after the gene therapy

- Subjects must possess the ability to give informed consent and express a willingness
to meet all of the expected requirements of the protocol for the duration of the study

Exclusion Criteria:

- PSA ≥ 100 ng/mL

- Prostate volume > 100 cc

- Pathologically positive lymph nodes or nodes > 1.0 cm on imaging (nodes > 1.0 cm but
biopsy negative are allowed.

- Evidence of M1 metastatic disease

- Prior invasive malignancy except for non-melanoma skin cancer within 5 years of
enrollment. Subjects must be disease-free for > 5 years

- Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy
for any reason

- If the subject had prior androgen deprivation therapy (ADT), the subject exhibited
biochemical failure while on ADT

- Prior systemic chemotherapy for the study cancer (prior chemotherapy for a different
cancer is allowed; however, subjects must be > 2 years post-completion of chemotherapy
at the time of registration. Subjects on Proscar therapy must stop to be eligible)

- Major surgery planned within 3 months of registration

- Severe, active co-morbidity defined as:

- New York Health Association Class II or greater congestive heart failure or active
ventricular arrhythmia requiring medication

- Chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness
requiring hospitalization within last 3 months or precluding study therapy at the time
of registration

- Acute infection

- Previous history of liver disease including hepatitis

- Immunosuppressive therapy including systemic corticosteroids (use of inhaled and
topical corticosteroids is permitted)

- Impaired immunity or susceptibility to serious viral infections

- Allergy to any product used in the protocol. If the subject has an allergy to
Ciproflaxin, another antibiotic can be substituted at the discretion of the treating
physician

- Serious medical or psychiatric illiness or concomitant medication, which, in the
judgement of the principal investigator, might interfere with the subject's ability to
respond to or tolerate the treatment or complete the trial