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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00004050
• Other study ID #: VCL-1102-202
• Secondary ID: UCLA-9901077-03B
• Status: Terminated
• Phase: Phase 2
• First received: December 10, 1999
• Last updated: July 25, 2014
• Start date: June 1999
• Est. completion date: April 2003

Study information

• Verified date: July 2014
• Source: Vical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: April 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• Leuvectin
Leuvectin injected intratumorally followed by prostatectomy

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Vical	Jonsson Comprehensive Cancer Center, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease recurrence	Measure timing and rate of disease recurrence	2 years	No
Secondary	Safety of Leuvectin			Yes