Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer

Phase 2TerminatedNCT00004050

Vical13 enrolled

Overview

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.

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. ACTUAL ACCRUAL: 13 patients were accrued for this study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

LeuvectinBIOLOGICAL

Leuvectin injected intratumorally followed by prostatectomy

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed stage II or III organ confined prostate cancer * Resectable disease (candidate for retropubic prostatectomy) * Gleason score at least 6 * Prostate specific antigen value (PSA) at least 5 ng/mL * No significant central nervous system (CNS) disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 80-100% * Eastern Cooperative Oncology Group (ECOG) 0-1 Life expectancy * Not specified Hematopoietic * White blood cell count (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; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) less than 3 times upper limit of normal * Prothrombin time (PT)/partial thromboplastin time (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 intrabdominal 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

Locations (2)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Disease recurrence

Measure timing and rate of disease recurrence

Time frame: 2 years

Secondary Outcomes

Safety of Leuvectin

Data from ClinicalTrials.gov

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