This trial is active, not recruiting.

Condition prostate cancer
Treatments il-2 plasmid dna/lipid complex, conventional surgery
Phase phase 2
Sponsor Jonsson Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date June 1999
Trial size 30 participants
Trial identifier NCT00004050, CDR0000067244, NCI-G99-1568, UCLA-9901077-03B, VCL-1102-202


RATIONALE: Inserting the gene for interleukin-2 into a person's cancer cells may improve the body's ability to fight cancer. Using leuvectin to deliver this gene may be an effective treatment for prostate cancer.

PURPOSE: Phase II trial to study the effectiveness of leuvectin followed by surgery in treating patients who have stage II or stage III prostate cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed stage II or III organ confined prostate cancer - Resectable disease (candidate for retropubic prostatectomy) - Gleason score at least 6 - PSA at least 5 ng/mL - No significant CNS disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 80-100% - ECOG 0-1 Life expectancy - Not specified Hematopoietic - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 9.0 g/dL Hepatic - Bilirubin normal SGOT/SGPT less than 3 times upper limit of normal - PT/PTT normal - Albumin greater than 3.0 g/dL - Hepatitis B surface antigen negative Renal - Creatinine normal Cardiovascular - No uncontrolled hypertension - No significant cardiovascular disease - No history of ventricular dysfunction or arrhythmia - No congestive heart failure - No symptoms of coronary artery disease - No prior myocardial infarction Other - No active autoimmune disease - No active infection requiring parenteral antibiotics - HIV negative - No significant psychiatric disorder that would preclude compliance - No other malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer - No diabetes mellitus - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for prostate cancer - At least 5 years since other prior chemotherapy Endocrine therapy - No prior glucocorticoids for prostate cancer - At least 5 years since other prior glucocorticoids Radiotherapy - No prior radiotherapy for prostate cancer - At least 5 years since other prior radiotherapy Surgery - See Disease Characteristics - At least 4 weeks since prior intrathoracic or intraabdominal surgery - At least 2 weeks since other major surgery Other - At least 10 days since prior anticoagulants or nonsteroidal antiinflammatory agents - No other neoadjuvant or concurrent anticancer drugs - No concurrent immunosuppressive drugs - No other concurrent experimental therapy - No concurrent parenteral antibiotics

Additional Information

Official title Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer
Description OBJECTIVES: - Assess the toxicity and tolerability of neoadjuvant leuvectin in patients with stage II or III prostate cancer. - Evaluate 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 a multicenter study. Patients receive leuvectin intraprostatically over 10-30 seconds under ultrasound guidance on day 0 followed by a second injection between days 4 and 7. Between days 8 and 14, patients undergo retropubic prostatectomy. All patients are followed at 2 months. Patients with a PSA no greater than 0.2 ng/mL are followed at 4 months and 6 months, every 3 months for 12 months, and then every 6 months for 3.5 years in the absence of disease progression or biochemical failure. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in February 2011.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).