Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00015977
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 7, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

Brief Summary:

RATIONALE: Vaccines made from a patient's white blood cells may make the body build an immune response to kill cancer cells. Interleukin-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-12 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy combined with interleukin-12 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: PSA prostate cancer vaccine Biological: recombinant interleukin-12 Phase 2

Detailed Description:


  • Determine whether immunization with prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells and interleukin-12 can promote specific T-cell priming in patients with metastatic hormone-refractory prostate cancer.
  • Determine the clinical response in patients treated with this regimen.

OUTLINE: Patients receive prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells subcutaneously (SC) on day 1 and interleukin-12 SC on days 1, 3, and 5. Treatment repeats every 21 days for 3-9 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 37 weeks.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Immunization With PSMA Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Prostate Cancer
Study Start Date : November 2001
Actual Primary Completion Date : March 2003
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: PSMA peptide vaccine
Immunization with PSMA peptide vaccine followed by injection of Interleukin-12 (IL-12) on Day 1 of a 21-day cycle. Additional injections of IL-12 given on Days 3 and 5 of each cycle.
Biological: PSA prostate cancer vaccine
Biological: recombinant interleukin-12
Other Name: IL-12, rhIL-12

Primary Outcome Measures :
  1. Disease response [ Time Frame: 63 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic adenocarcinoma of the prostate
  • HLA-A2 positive
  • Progressive measurable systemic disease

    • PSA at least 5 ng/mL with 2 consecutive rising PSA levels at least 1 week apart and no measurable disease OR
    • Objective evidence of disease progression by a 20% increase in the sum of longest diameter of all target lesions or evidence of new lesions by CT or bone scan regardless of PSA status
    • Lesions must be at least 1 cm to be considered measurable
    • Progressive systemic disease after discontinuation of anti-androgen therapy
  • Previously treated with orchiectomy (testosterone less than 50 ng/mL) OR luteinizing hormone-releasing hormone (LHRH) analogue therapy with or without anti-androgens

    • If on LHRH analogue therapy, must continue therapy during study
  • Brain metastases allowed if previously treated, clinically stable, and weaned from prior corticosteroids



  • Over 18

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 12 weeks


  • Absolute neutrophil count greater than 1,500/mm^3
  • Hemoglobin greater than 9 g/dL
  • Platelet count greater than 100,000/mm^3
  • No active gastrointestinal bleeding


  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGPT normal
  • Hepatitis B surface antigen negative


  • Creatinine less than 1.5 times ULN
  • Calcium less than 11 mg/dL


  • No significant cardiovascular disease
  • No cardiac arrhythmia requiring therapy


  • Fertile patients must use effective barrier contraception
  • No intrinsic immunosuppression
  • HIV negative
  • No serious concurrent infection
  • No psychiatric illness that would preclude study compliance
  • No clinically significant autoimmune disease
  • No uncontrolled peptic ulcer disease
  • No history of inflammatory bowel disease


Biologic therapy:

  • At least 4 weeks since prior biologic therapy


  • Not specified

Endocrine therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior flutamide
  • At least 6 weeks since prior bicalutamide or nilutamide
  • No concurrent systemic corticosteroids except physiologic replacement doses


  • Not specified


  • See Disease Characteristics


  • No concurrent immunosuppressive drugs (e.g., cyclosporine)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00015977

United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)
Study Chair: Thomas F. Gajewski, MD, PhD University of Chicago

Responsible Party: University of Chicago Identifier: NCT00015977     History of Changes
Other Study ID Numbers: 9845
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: March 2014

Keywords provided by University of Chicago:
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents