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

Vical

Status and phase

Terminated

Phase 2

Conditions

Prostate Cancer

Treatments

Biological: Leuvectin

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00004050

NCI-G99-1568 (Other Identifier)

UCLA-9901077-03B (Other Identifier)

VCL-1102-202

CDR0000067244 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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