Prostate Cancer Clinical Trial
Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer
Summary
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.
Full 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.
ACTUAL ACCRUAL: 13 patients were accrued for this study.
Eligibility Criteria
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
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There are 2 Locations for this study
Los Angeles California, 90095, United States
Cleveland Ohio, 44195, United States
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