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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Arie Belldegrun, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067244

NCT ID:

NCT00004050

Start Date:

June 1999

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195