Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer

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. Identifier: NCT00004050
Recruitment Status : Terminated (Development in prostate cancer indication halted)
First Posted : October 29, 2003
Last Update Posted : July 29, 2014
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):

Brief Summary:

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

Detailed Description:


  • 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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Leuvectin
2 intratumoral injections of 1000 ug of Leuvectin
Biological: Leuvectin
Leuvectin injected intratumorally followed by prostatectomy
Other Name: Interleukin-2 (IL-2) plasmid DNA/lipid complex

Primary Outcome Measures :
  1. Disease recurrence [ Time Frame: 2 years ]
    Measure timing and rate of disease recurrence

Secondary Outcome Measures :
  1. Safety of Leuvectin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed stage II or III organ confined prostate cancer

    • Resectable disease (candidate for retropubic prostatectomy)
  • Gleason score at least 6
  • Prostate specific antigen value (PSA) at least 5 ng/mL
  • No significant central nervous system (CNS) disease



  • 18 and over

Performance status

  • Karnofsky 80-100%
  • Eastern Cooperative Oncology Group (ECOG) 0-1

Life expectancy

  • Not specified


  • White blood cell count (WBC) greater than 3,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 9.0 g/dL


  • Bilirubin normal; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) less than 3 times upper limit of normal
  • Prothrombin time (PT)/partial thromboplastin time (PTT) normal
  • Albumin greater than 3.0 g/dL
  • Hepatitis B surface antigen negative


  • Creatinine normal


  • No uncontrolled hypertension
  • No significant cardiovascular disease
  • No history of ventricular dysfunction or arrhythmia
  • No congestive heart failure
  • No symptoms of coronary artery disease
  • No prior myocardial infarction


  • No active autoimmune disease
  • No active infection requiring parenteral antibiotics
  • HIV negative
  • No significant psychiatric disorder that would preclude compliance
  • No other malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer
  • No diabetes mellitus
  • Fertile patients must use effective contraception


Biologic therapy

  • Not specified


  • No prior chemotherapy for prostate cancer
  • At least 5 years since other prior chemotherapy

Endocrine therapy

  • No prior glucocorticoids for prostate cancer
  • At least 5 years since other prior glucocorticoids


  • No prior radiotherapy for prostate cancer
  • At least 5 years since other prior radiotherapy


  • See Disease Characteristics
  • At least 4 weeks since prior intrathoracic or intrabdominal surgery
  • At least 2 weeks since other major surgery


  • At least 10 days since prior anticoagulants or nonsteroidal antiinflammatory agents
  • No other neoadjuvant or concurrent anticancer drugs
  • No concurrent immunosuppressive drugs
  • No other concurrent experimental therapy
  • No concurrent parenteral antibiotics

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 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
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Arie Belldegrun, MD, FACS Jonsson Comprehensive Cancer Center

Responsible Party: Vical Identifier: NCT00004050     History of Changes
Other Study ID Numbers: VCL-1102-202
UCLA-9901077-03B ( Other Identifier: UCLA )
CDR0000067244 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-G99-1568 ( Other Identifier: NCI )
First Posted: October 29, 2003    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014

Keywords provided by Vical:
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs