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Prostate CancerPhase 2NCT00004050

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

A Phase 2 study testing Leuvectin in people with Prostate Cancer, run by Vical at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Leuvectin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
2 sitesUnited States
Study dates
Jun 1999to Apr 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

About this study

Official title: Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer

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.

Conditions
Prostate Cancer
Being tested
Leuvectin
Keywords
stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LeuvectinBiological

    Also called Interleukin-2 (IL-2) plasmid DNA/lipid complex

    Leuvectin injected intratumorally followed by prostatectomy

Study groups in NCT00004050
Study groupRoleWhat they receive
LeuvectinExperimental2 intratumoral injections of 1000 ug of Leuvectin
Receives: Biological: Leuvectin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease recurrence

    Measure timing and rate of disease recurrence

    Measured: 2 years

Secondary outcomes (1)

  1. Safety of Leuvectin

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2003 (estimated)
  2. Study startJun 1999
  3. Primary completionApr 2003
  4. Study completionApr 2003

Why it stopped: Development in prostate cancer indication halted

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004050
Sponsor's protocol ID
VCL-1102-202
Other IDs
UCLA-9901077-03B, CDR0000067244, NCI-G99-1568
Status last verified
Jul 2014
First submitted
10 Dec 1999
Last updated
29 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Leuvectin in people with Prostate Cancer, run by Vical at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Development in prostate cancer indication halted). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease recurrence (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00004050.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.

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