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| ID | Type | Description | Link |
|---|---|---|---|
| UCCRC-9845 | |||
| NCI-1192 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSMA peptide vaccine | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSA prostate cancer vaccine | Biological |
| ||
| recombinant interleukin-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease response | 63 days |
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DISEASE CHARACTERISTICS:
Histologically confirmed metastatic adenocarcinoma of the prostate
HLA-A2 positive
Progressive measurable systemic disease
Previously treated with orchiectomy (testosterone less than 50 ng/mL) OR luteinizing hormone-releasing hormone (LHRH) analogue therapy with or without anti-androgens
Brain metastases allowed if previously treated, clinically stable, and weaned from prior corticosteroids
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas F. Gajewski, MD, PhD | University of Chicago | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
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| Biological |
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|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D053765 | Interleukin-12 Subunit p35 |
| D018664 | Interleukin-12 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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