Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00005072|
Recruitment Status : Terminated (Development in prostate cancer indication halted)
First Posted : November 4, 2003
Last Update Posted : July 29, 2014
RATIONALE: Inserting the gene for interleukin-2 into a person's prostate cancer cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of Leuvectin in treating patients who have locally recurrent prostate cancer after receiving treatment with radiation therapy.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: Leuvectin||Phase 1 Phase 2|
OBJECTIVES: I. Determine the toxicity and tolerability of Leuvectin in patients with locally recurrent organ-confined prostate cancer after radiotherapy. II. Determine 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 an open-label, multicenter study. Patients receive Leuvectin intraprostatically over 10-30 seconds under transrectal ultrasound guidance on days 0 and 14. Patients are re-evaluated at week 10. Treatment repeats every 10-11 weeks or 1-6 days after completion of each week 10 re-evaluation for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years in the absence of disease progression.
ACTUAL ACCRUAL: A total of 25 patients were accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study Evaluating the Safety and Efficacy of Leuvectin Immunotherapy for the Treatment of Locally Recurrent Prostate Cancer Following Radiation Therapy (Summary Last Updated: 02/2001)|
|Study Start Date :||November 2000|
|Actual Primary Completion Date :||April 2003|
|Actual Study Completion Date :||April 2003|
1000 ug of Leuvectin injected intratumorally
Other Name: Interleukin-2 (IL-2) plasmid DNA/lipid complex
- 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): NCT00005072
|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|