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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00015977 |
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: PSA prostate cancer vaccine Biological: recombinant interleukin-12 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of Immunization With PSMA Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Prosate Cancer |
| Study Start Date: | November 2001 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Study Chair: | Thomas F. Gajewski, MD, PhD | University of Chicago |
More Information
| Study ID Numbers: | CDR0000068578, UCCRC-9845, NCI-1192 |
| Study First Received: | May 6, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00015977 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
|
Interleukin-12 Genital Neoplasms, Male Prostatic Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Adjuvants, Immunologic Urogenital Neoplasms |
Genital Diseases, Male Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Prostatic Neoplasms |