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TerminatedNCT00004050Updated Jul 29, 2014

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

A Phase 2 interventional study of Leuvectin in Prostate Cancer, sponsored by Vical. Terminated at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-29.

Sponsored by Vical · Phase 2, Interventional, and Treatment

Why this study was terminated
Development in prostate cancer indication halted
Phase
Phase 2
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the detailed description

OBJECTIVES:

  • 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
03

In context

Prostatic Neoplasms

6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 13 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Vical is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

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

Life expectancy

  • Not specified

Hematopoietic

  • 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

Hepatic

  • 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

Renal

  • Creatinine normal

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Radiotherapy

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

Surgery

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

Other

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Leuvectin

    2 intratumoral injections of 1000 ug of Leuvectin

    Biological: Leuvectin

Interventions

  • BiologicalLeuvectin

    Leuvectin injected intratumorally followed by prostatectomy

    Also known as: Interleukin-2 (IL-2) plasmid DNA/lipid complex

06

What researchers measure

Primary outcomes

  1. Disease recurrence

    Measure timing and rate of disease recurrence

    Time frame: 2 years

Secondary outcomes

  1. Safety of Leuvectin

07

Study locations

2 sites
  • Jonsson Comprehensive Cancer Center, UCLA
    Los Angeles, California 90095-1781, United States
  • Cleveland Clinic Taussig Cancer Center
    Cleveland, Ohio 44195, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00004050
Lead sponsor
Vical
Collaborators
Jonsson Comprehensive Cancer Center, National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 29, 2003
Start date
Jun 1999
Primary completion
Apr 2003
Completion
Apr 2003
Last update
Jul 29, 2014

Study contacts

Arie Belldegrun, MD, FACS
study chair · Jonsson Comprehensive Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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