Clinical trial NCT00004050: Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer
Official title: Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
Lead sponsor: Vical
Sponsor class: INDUSTRY
Collaborators: name: Jonsson Comprehensive Cancer Center
name: National Cancer Institute (NCI)
First posted: 2003-10-29
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disease recurrence
timeFrame: 2 years
Secondary outcomes:
measure: Safety of Leuvectin
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Arie Belldegrun, MD, FACS
role: STUDY_CHAIR
References: