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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004050
First received: December 10, 1999
Last updated: February 18, 2011
Last verified: July 2002
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Biological: IL-2 plasmid DNA/lipid complex
Procedure: conventional surgery
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: June 1999
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.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage II or III organ confined prostate cancer

    • Resectable disease (candidate for retropubic prostatectomy)
  • Gleason score at least 6
  • PSA at least 5 ng/mL
  • No significant CNS disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 80-100%
  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • 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 SGOT/SGPT less than 3 times upper limit of normal
  • PT/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 intraabdominal 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004050

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Arie Belldegrun, MD, FACS Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00004050     History of Changes
Other Study ID Numbers: CDR0000067244, UCLA-9901077-03B, VCL-1102-202, NCI-G99-1568
Study First Received: December 10, 1999
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013