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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 is ongoing, but not recruiting participants.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Official Title  Phase II Study of Immunization With PSMA Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Prosate Cancer
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.

Detailed Description

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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Prostate Cancer
Intervention  Drug: PSA prostate cancer vaccine
Drug: recombinant interleukin-12
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  November 2001
Completion Date
Eligibility Criteria 

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)
Gender Male
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00015977
Organization ID CDR0000068578
Secondary IDs †† UCCRC-9845, NCI-1192
Study Sponsor  University of Chicago
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Thomas F. Gajewski, MD, PhD     University of Chicago    
Information Provided By National Cancer Institute (NCI)
Verification Date May 2003
First Received Date  May 6, 2001
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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