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

NCT ID: NCT00004050

Last Updated: 2014-07-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-06-30
• Study Completion Date: 2003-04-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Leuvectin

2 intratumoral injections of 1000 ug of Leuvectin

Group Type: EXPERIMENTAL

Leuvectin

Intervention Type: BIOLOGICAL

Leuvectin injected intratumorally followed by prostatectomy

Interventions

Leuvectin

Leuvectin injected intratumorally followed by prostatectomy

Intervention Type: BIOLOGICAL

Other Intervention Names

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

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arie Belldegrun, MD, FACS

Role: STUDY_CHAIR

Jonsson Comprehensive Cancer Center

Locations

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

UCLA-9901077-03B

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000067244

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-G99-1568

Identifier Type: OTHER

Identifier Source: secondary_id

VCL-1102-202

Identifier Type: -

Identifier Source: org_study_id