- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004050
Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer
Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer
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.
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Leuvectin
2 intratumoral injections of 1000 ug of Leuvectin
|
Leuvectin injected intratumorally followed by prostatectomy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease recurrence
Time Frame: 2 years
|
Measure timing and rate of disease recurrence
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2 years
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety of Leuvectin
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Arie Belldegrun, MD, FACS, Jonsson Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VCL-1102-202
- UCLA-9901077-03B (Other Identifier: UCLA)
- CDR0000067244 (Registry Identifier: PDQ (Physician Data Query))
- NCI-G99-1568 (Other Identifier: NCI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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