Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004929
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2000-03-07
Brief Title:
Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE Phase II trial to study the effectiveness of vaccine therapy given with QS21 in treating patients who have progressive prostate cancer
Detailed Description:
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 andor 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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1697 | None | None | None |
| MSKCC-99056 | None | None | None |