Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00030602|
Recruitment Status : Completed
First Posted : February 19, 2004
Last Update Posted : November 5, 2019
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have recurrent prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: PSA prostate cancer vaccine Biological: incomplete Freund's adjuvant||Phase 2|
OBJECTIVES: I. Determine the effect of PSA-3 peptide vaccine emulsified in Montanide ISA-51 on PSA levels in patients with recurrent prostate cancer. II. Determine the toxicity of this regimen in these patients. III. Determine whether the T lymphocyte immune response to PSA-3 and HLA-A2 antigen-presenting cells that endogenously produce PSA is increased in patients treated with this regimen. IV. Determine the duration of the PSA and/or immune responses in patients treated with this regimen. V. Correlate immune and PSA responses in patients treated with this regimen. VI. Determine the efficacy of a second (boost) vaccination with this regimen in patients with a PSA or immune response.
OUTLINE: This is a multicenter study. Patients receive PSA-3 peptide vaccine emulsified in Montanide ISA-51 subcutaneously in 2 sites on days 1, 8, 15, and 22 in the absence of unacceptable toxicity. Patients who show an immune or prostate specific antigen (PSA) response are followed until disease progression, defined as a diminution or disappearance of an immune response or 2 consecutive increases in PSA over the nadir. Patients are eligible for a second series of injections at the time of progression.
PROJECTED ACCRUAL: A total of 14-44 patients will be accrued for this study within 12-18 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase 2 Study Of Prostate Specific Antigen-3 (PSA-3) (NSC # 694155) With Montanide (NSC #675756) Vaccination In Patients With Prostate Cancer Recurrent|
|Actual Study Start Date :||January 2000|
|Actual Primary Completion Date :||December 2001|
|Actual Study Completion Date :||December 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030602
|Study Chair:||Nancy A. Dawson, MD||University of Maryland Greenebaum Cancer Center|