Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00004929|
Recruitment Status : Completed
First Posted : June 18, 2004
Last Update Posted : January 31, 2013
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 given with QS21 in treating patients who have progressive prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: MUC-2-KLH vaccine Biological: QS21||Phase 1|
OBJECTIVES: I. Determine if immunization with glycosylated MUC-2 antigen with keyhole limpet hemocyanin (KLH) conjugate plus immunological adjuvant QS21 induces an antibody, helper T cell, and/or cytotoxic T cell response against glycosylated MUC-2 in patients with progressive prostate cancer. II. Determine the safety of this treatment regimen in this patient population. III. Determine the effect of glycosylated MUC-2 antigen with KLH conjugate on the T cell response against MUC-2 and by skin testing in these patients. IV. Assess the post immunization changes in prostate specific antigen levels and other objective parameters of disease including radionuclide bone scan and/or measurable disease in these patients.
OUTLINE: Patients receive vaccination with glycosylated MUC-2 antigen with keyhole limpet hemocyanin conjugate subcutaneously (SQ) plus immunological adjuvant QS21 SQ on weeks 1-3, 7, 15, and 27 for a total of 6 vaccinations. Patients are followed every 3 months for 1 year or until disease progression.
PROJECTED ACCRUAL: A total of 3-15 patients will be accrued for this study within 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vaccination of Prostate Cancer Patients With MUC-2-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Examining the Immunogenicity of Glycosylated MUC-2-KLH Peptide Conjugate Vaccine|
|Study Start Date :||September 1999|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
Patients receive vaccination with glycosylated MUC-2 antigen with keyhole limpet hemocyanin conjugate subcutaneously (SQ) plus immunological adjuvant QS21 SQ on weeks 1-3, 7, 15, and 27 for a total of 6 vaccinations. Patients are followed every 3 months for 1 year or until disease progression.
|Biological: MUC-2-KLH vaccine Biological: QS21|
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): NCT00004929
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Susan Slovin, MD, PhD||Memorial Sloan Kettering Cancer Center|