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Home > "L" Clinical Trials Conditions > Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer  Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer
Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer
For Condition: stage 1 prostate cancer,stage 2 prostate cancer,recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven locally recurrent organ-confined prostate cancer after external beam radiotherapy, radiation seed implants, or cryosurgery - Gleason score at least 6 - PSA at least 1.0 ng/mL with 2 consecutive rises in PSA at least 2 weeks apart, of which the second increase is greater than the first, after achieving a nadir; Must have at least 3 recorded PSA values over a minimum of the last 3 months to determine the slope - Patients must have declined additional conventional treatment or be ineligible for conventional treatment of their prostate cancer; No metastasis by bone scan - No significant CNS disease --Prior/Concurrent Therapy-- - Biologic therapy: No prior leuvectin - Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or hydroxyurea) - Endocrine therapy: No prior hormonal therapy for prostate cancer - Radiotherapy: See Disease Characteristics; At least 3 weeks since prior radiotherapy - Surgery: At least 1 month since prior intrathoracic or intra-abdominal surgery; At least 2 weeks since other prior major surgery - Other: At least 10 days since prior anticoagulants or non-steroidal anti-inflammatory agents; No neoadjuvant or other concurrent anticancer drug therapy; No concurrent immunosuppressive drugs; No other concurrent experimental therapy --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 80-100% OR ECOG 0 or 1 - Life expectancy: Not specified - Hematopoietic: WBC greater than 3,000/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 9.0 g/dL - Hepatic: Bilirubin normal SGOT or SGPT less than 3 times upper limit of normal; Albumin greater than 3 g/dL PT and PTT normal; Hepatitis B surface antigen negative - Renal: Creatinine normal - Cardiovascular: No uncontrolled hypertension; No significant cardiovascular disease, e.g.: History of ventricular dysfunction; Congestive heart failure; Symptoms of coronary artery disease; History of any ventricular arrhythmia; Prior myocardial infarction - Other: HIV negative; Fertile patients must use effective double-barrier contraception during and for 3 months after study; No active autoimmune disease; No active infection requiring IV antibiotics; No uncontrolled diabetes mellitus; No significant psychiatric disorder that would preclude study; No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ArieBelldegrun, Study Chair, Jonsson Comprehensive Cancer Center
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000067677; UCLA-9906108,NCI-G00-1721,VCL-1102-203
Study Start Date: November 2000
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005072
Other Recurrent Prostate Cancer Studies:
1. Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
2. Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer
3. Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer
4. Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer
5. Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer
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