Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005632
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2000-05-02
Brief Title:
Vaccine Therapy Plus QS21 in Treating Patients With 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-1-KLH Conjugate Plus the Immunological Adjuvant QS21 A Trial Examining the Immunogenicity of MUC-1 Glycopeptide Conjugate
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 Combining a vaccine with QS21 may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of vaccine therapy plus immune adjuvant QS21 in treating patients who have prostate cancer
PURPOSE Phase I trial to study the effectiveness of vaccine therapy plus immune adjuvant QS21 in treating patients who have prostate cancer
Detailed Description:
OBJECTIVES I Determine if immunization with glycosylated MUC-1 antigen containing MUC-1 106 with keyhole limpet hemocyanin conjugate plus immunological adjuvant QS21 induces an antibody helper T cell andor cytotoxic T cell response against MUC-1 in patients with prostate cancer expressing MUC-1 II Determine post-immunization changes in PSA levels and other objective parameters or disease radionuclide bone scan andor measurable disease if present in these patients after receiving this therapy
OUTLINE Patients receive glycosylated MUC-1 antigen containing MUC-1 106 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 documented disease progression
OUTLINE Patients receive glycosylated MUC-1 antigen containing MUC-1 106 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 documented disease progression
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-G00-1773 | None | None | None |
| MSKCC-99040 | None | None | None |