NCT00004050

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Jun 1999

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 29, 2003

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

3.8 years

First QC Date

December 10, 1999

Last Update Submit

July 25, 2014

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancerstage IIA prostate cancerstage III prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Disease recurrence

    Measure timing and rate of disease recurrence

    2 years

Secondary Outcomes (1)

  • Safety of Leuvectin

Study Arms (1)

Leuvectin

EXPERIMENTAL

2 intratumoral injections of 1000 ug of Leuvectin

Biological: Leuvectin

Interventions

LeuvectinBIOLOGICAL

Leuvectin injected intratumorally followed by prostatectomy

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

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

LeuvectinInterleukin-2

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • Arie Belldegrun, MD, FACS

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 1999

First Posted

October 29, 2003

Study Start

June 1, 1999

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations

US(2)