Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003819
Status:
COMPLETED
Last Update Posted:
2013-03-19
First Post:
1999-11-01
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 Thompson-Friedenreich TFc-KLH Conjugate Plus the Immunological Adjuvant QS21 A Trial Comparing TFc-KLH Doses
Status:
COMPLETED
Status Verified Date:
2013-03
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 I trial to study the effectiveness of vaccine therapy given with QS21 in treating patients who have progressive prostate cancer
PURPOSE Phase I trial to study the effectiveness of vaccine therapy given with QS21 in treating patients who have progressive prostate cancer
Detailed Description:
OBJECTIVES I Determine the optimal dose of Thompson-Friedenreich TFc-keyhole limpet hemocyanin KLH conjugate plus adjuvant QS21 that induces an antibody response in patients with prostate cancer II Determine the safety of the TFc-KLH conjugate prepared using an MBS heterobifunctional linker plus QS21 III Assess postimmunization changes in prostate specific antigen levels and other objective parameters of disease in these patients
OUTLINE This is a dose escalation study Patients receive TFc-KLH conjugate with adjuvant QS21 subcutaneously weekly for 3 weeks then once during weeks 7 and 19 Cohorts of 5 patients each receive escalating doses of TFc-KLH vaccine until the optimal dose based on antibody response is reached Patients are followed monthly for 6 months then every 3 months for 1 year
OUTLINE This is a dose escalation study Patients receive TFc-KLH conjugate with adjuvant QS21 subcutaneously weekly for 3 weeks then once during weeks 7 and 19 Cohorts of 5 patients each receive escalating doses of TFc-KLH vaccine until the optimal dose based on antibody response is reached Patients are followed monthly for 6 months then every 3 months for 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-G99-1510 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |
| MSKCC-98048 | None | None | None |