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Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer

This study has been terminated.
(Development in prostate cancer indication halted)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005072
First Posted: November 4, 2003
Last Update Posted: July 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Vical
  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: Leuvectin Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Vical:

Primary Outcome Measures:
  • Safety of Leuvectin

Enrollment: 25
Study Start Date: November 2000
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Leuvectin
Leuvectin
Biological: Leuvectin
1000 ug of Leuvectin injected intratumorally
Other Name: Interleukin-2 (IL-2) plasmid DNA/lipid complex

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.

ACTUAL ACCRUAL: A total of 25 patients were accrued for this study.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 of at least 6. Prostate specific antigen values (PSA) of 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 central nervous system (CNS) disease.

PATIENT CHARACTERISTICS: Age: 18 and over. Performance status: Karnofsky 80-100% OR Eastern Cooperative Oncology Group (ECOG) 0 or 1. Life expectancy: Not specified. Hematopoietic: White blood cell count (WBC) greater than 3,000/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 9.0 g/dL. Hepatic: Bilirubin normal. Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) less than 3 times upper limit of normal. Albumin greater than 3 g/dL. Prothrombin time (PT) and partial thromboplastin time (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
Information from the National Library of Medicine

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


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
Vical
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Arie Belldegrun, MD, FACS Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Vical
ClinicalTrials.gov Identifier: NCT00005072     History of Changes
Other Study ID Numbers: VCL-1102-203
UCLA-9906108 ( Other Identifier: UCLA )
CDR0000067677 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-G00-1721 ( Other Identifier: NCI )
First Submitted: April 6, 2000
First Posted: November 4, 2003
Last Update Posted: July 29, 2014
Last Verified: July 2014

Keywords provided by Vical:
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
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs