Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of 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.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Arie Belldegrun, MD, FACS
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000067244
NCT ID:
NCT00004050
Start Date:
June 1999
Completion Date:
Related Keywords:
- Prostate Cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
