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Clinical Trial: Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
This study is no longer recruiting patients.
Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer | Drug: PSA prostate cancer vaccine Drug: interleukin-12 Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological response modifier therapy Procedure: cytokine therapy Procedure: growth factor antagonist therapy Procedure: interleukin therapy Procedure: non-tumor cell derivative vaccine Procedure: vaccine therapy | Phase II |
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Immunization With Prostate-Specific Membrane Antigen-Pulsed Autologous Peripheral Blood Mononuclear Cells and Interleukin-12 in Patients With Metastatic Hormone-Refractory Prostate Cancer
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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)
Location Information
Thomas F. Gajewski, MD, PhD, Study Chair, University of Chicago Cancer Research Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2003
Last Updated: October 13, 2004
Record first received: May 6, 2001
ClinicalTrials.gov Identifier: NCT00015977
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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