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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00015977
First received: May 6, 2001
Last updated: March 6, 2014
Last verified: March 2014

May 6, 2001
March 6, 2014
November 2001
March 2003   (final data collection date for primary outcome measure)
Disease response [ Time Frame: 63 days ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00015977 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Phase II Study of Immunization With PSMA Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Prostate Cancer

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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Biological: PSA prostate cancer vaccine
  • Biological: recombinant interleukin-12
    Other Name: IL-12, rhIL-12
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.
Interventions:
  • Biological: PSA prostate cancer vaccine
  • Biological: recombinant interleukin-12
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
January 2005
March 2003   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • 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

Hepatic:

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

Renal:

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

Cardiovascular:

  • No significant cardiovascular disease
  • No cardiac arrhythmia requiring therapy

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy

Chemotherapy:

  • 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

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Other:

  • No concurrent immunosuppressive drugs (e.g., cyclosporine)
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00015977
9845, UCCRC-9845, NCI-1192
No
University of Chicago
University of Chicago
National Cancer Institute (NCI)
Study Chair: Thomas F. Gajewski, MD, PhD University of Chicago
University of Chicago
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP