search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Leuvectin
Sponsored by
Vical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA
  • Cleveland Clinic Taussig Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Leuvectin

Arm Description

2 intratumoral injections of 1000 ug of Leuvectin

Outcomes

Primary Outcome Measures

Disease recurrence
Measure timing and rate of disease recurrence

Secondary Outcome Measures

Safety of Leuvectin

Full Information

First Posted
December 10, 1999
Last Updated
July 25, 2014
Sponsor
Vical
Collaborators
Jonsson Comprehensive Cancer Center, National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00004050
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
Development in prostate cancer indication halted
Study Start Date
June 1999 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vical
Collaborators
Jonsson Comprehensive Cancer Center, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Leuvectin
Arm Type
Experimental
Arm Description
2 intratumoral injections of 1000 ug of Leuvectin
Intervention Type
Biological
Intervention Name(s)
Leuvectin
Other Intervention Name(s)
Interleukin-2 (IL-2) plasmid DNA/lipid complex
Intervention Description
Leuvectin injected intratumorally followed by prostatectomy
Primary Outcome Measure Information:
Title
Disease recurrence
Description
Measure timing and rate of disease recurrence
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Safety of Leuvectin

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arie Belldegrun, MD, FACS
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs