Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005072
First received: April 6, 2000
Last updated: February 18, 2011
Last verified: July 2002
  Purpose

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 Intervention Phase
Prostate Cancer
Biological: IL-2 plasmid DNA/lipid complex
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2000
Detailed Description:

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.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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 participation 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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005072

Locations
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
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Arie Belldegrun, MD, FACS Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005072     History of Changes
Other Study ID Numbers: CDR0000067677, UCLA-9906108, VCL-1102-203, NCI-G00-1721
Study First Received: April 6, 2000
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014