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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00010127 |
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill prostate tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Biological: therapeutic autologous dendritic cells |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA |
Study Start Date: | November 2000 |
OBJECTIVES:
OUTLINE: This is a dose escalation study.
Tumor tissue and peripheral blood stem cells are collected from patients and cultured in vitro with sargramostim (GM-CSF) and interleukin-4 for 7 days to produce dendritic cells (DC). Patients receive autologous DC transfected with autologous prostate carcinoma RNA intradermally once weekly on weeks 0-3 for a total of 4 doses.
Cohorts of 3-6 patients receive escalating doses of DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at weeks 6, 8, 10, and 12; every 3 months for 9 months; and then annually for 2 years.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study within 20 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic adenocarcinoma of the prostate
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 |
Study Chair: | Johannes Vieweg, MD | Duke University |
Study ID Numbers: | CDR0000068447, DUMC-000759-00-4R1, DUMC-DORIS-99043, NCI-G00-1910 |
Study First Received: | February 2, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00010127 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage IV prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male |
Adenocarcinoma Prostatic Neoplasms Carcinoma |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |