Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer
Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer
RATIONALE: Inserting the gene for interleukin-2 into a person's prostate cancer cells may
 make the body build an immune response to kill tumor cells.

 PURPOSE: Phase I/II trial to study the effectiveness of Leuvectin in treating patients who
 have locally recurrent prostate cancer after receiving treatment with radiation therapy.
OBJECTIVES: I. Determine the toxicity and tolerability of Leuvectin in patients with locally
 recurrent organ-confined prostate cancer after radiotherapy. II. Determine the efficacy of
 this regimen in preventing or delaying manifestations of disease progression as demonstrated
 by biochemical failure or clinical recurrence in this patient population.

 OUTLINE: This is an open-label, multicenter study. Patients receive Leuvectin
 intraprostatically over 10-30 seconds under transrectal ultrasound guidance on days 0 and 14.
 Patients are re-evaluated at week 10. Treatment repeats every 10-11 weeks or 1-6 days after
 completion of each week 10 re-evaluation for a maximum of 3 courses in the absence of disease
 progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and
 then every 6 months for 2 years in the absence of disease progression.

 ACTUAL ACCRUAL: A total of 25 patients were accrued for this study.
DISEASE CHARACTERISTICS: Histologically proven locally recurrent organ-confined prostate
 cancer after external beam radiotherapy, radiation seed implants, or cryosurgery. Gleason
 score of at least 6. Prostate specific antigen values (PSA) of at least 1.0 ng/mL with 2
 consecutive rises in PSA at least 2 weeks apart, of which the second increase is greater
 than the first, after achieving a nadir. Must have at least 3 recorded PSA values over a
 minimum of the last 3 months to determine the slope. Patients must have declined additional
 conventional treatment or be ineligible for conventional treatment of their prostate
 cancer. No metastasis by bone scan. No significant central nervous system (CNS) disease.

 PATIENT CHARACTERISTICS: Age: 18 and over. Performance status: Karnofsky 80-100% OR Eastern
 Cooperative Oncology Group (ECOG) 0 or 1. Life expectancy: Not specified. Hematopoietic:
 White blood cell count (WBC) greater than 3,000/mm3. Platelet count greater than
 100,000/mm3. Hemoglobin greater than 9.0 g/dL. Hepatic: Bilirubin normal. Serum glutamic
 oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) less than 3
 times upper limit of normal. Albumin greater than 3 g/dL. Prothrombin time (PT) and partial
 thromboplastin time (PTT) normal. Hepatitis B surface antigen negative. Renal: Creatinine
 normal. Cardiovascular: No uncontrolled hypertension. No significant cardiovascular
 disease, e.g.: History of ventricular dysfunction; Congestive heart failure; Symptoms of
 coronary artery disease; History of any ventricular arrhythmia; Prior myocardial
 infarction. Other: HIV negative. Fertile patients must use effective double-barrier
 contraception during and for 3 months after study participation. No active autoimmune
 disease. No active infection requiring IV antibiotics. No uncontrolled diabetes mellitus.
 No significant psychiatric disorder that would preclude study. No other malignancy within
 the past 5 years except adequately treated basal cell or squamous cell skin cancer.

 PRIOR CONCURRENT THERAPY: Biologic therapy: No prior Leuvectin. Chemotherapy: At least 3
 weeks since prior chemotherapy (6 weeks for mitomycin or hydroxyurea). Endocrine therapy:
 No prior hormonal therapy for prostate cancer. Radiotherapy: See Disease Characteristics.
 At least 3 weeks since prior radiotherapy. Surgery: At least 1 month since prior
 intrathoracic or intra-abdominal surgery. At least 2 weeks since other prior major surgery.
 Other: At least 10 days since prior anticoagulants or non-steroidal anti-inflammatory
 agents. No neoadjuvant or other concurrent anticancer drug therapy. No concurrent
 immunosuppressive drugs. No other concurrent experimental therapy.