Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00004050|
Recruitment Status : Terminated (Development in prostate cancer indication halted)
First Posted : October 29, 2003
Last Update Posted : July 29, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: Leuvectin||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer|
|Study Start Date :||June 1999|
|Actual Primary Completion Date :||April 2003|
|Actual Study Completion Date :||April 2003|
2 intratumoral injections of 1000 ug of Leuvectin
Leuvectin injected intratumorally followed by prostatectomy
Other Name: Interleukin-2 (IL-2) plasmid DNA/lipid complex
- Disease recurrence [ Time Frame: 2 years ]Measure timing and rate of disease recurrence
- Safety of Leuvectin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004050
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Arie Belldegrun, MD, FACS||Jonsson Comprehensive Cancer Center|