Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016146
Status:
COMPLETED
Last Update Posted:
2013-03-19
First Post:
2001-05-06
Brief Title:
Vaccine Therapy Plus Biological Therapy 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 A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates A Dose-Escalating Trial Studying The Immunogenicity And Safety Of The Immunological Adjuvant GPI-0100
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 Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing Combining vaccine therapy with biological therapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness in combining vaccine therapy and biological therapy in treating patients who have relapsed prostate cancer
PURPOSE Phase I trial to study the effectiveness in combining vaccine therapy and biological therapy in treating patients who have relapsed prostate cancer
Detailed Description:
OBJECTIVES
Determine the optimal in terms of antibody response and safe dose range of glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant GPI-0100 in patients with biochemically relapsed prostate cancer
Assess post-immunization changes in prostate-specific antigen levels and other objective parameters of disease in these patients
OUTLINE This is a dose-escalation study of GPI-0100
Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant GPI-0100 subcutaneously weekly on weeks 0-2 6 14 and 26 in the absence of unacceptable toxicity or disease progression
Cohorts of 5 patients receive escalating doses of GPI-0100 until the optimal dose based on antibody response is reached
Patients are followed every 3 months
Determine the optimal in terms of antibody response and safe dose range of glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant GPI-0100 in patients with biochemically relapsed prostate cancer
Assess post-immunization changes in prostate-specific antigen levels and other objective parameters of disease in these patients
OUTLINE This is a dose-escalation study of GPI-0100
Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant GPI-0100 subcutaneously weekly on weeks 0-2 6 14 and 26 in the absence of unacceptable toxicity or disease progression
Cohorts of 5 patients receive escalating doses of GPI-0100 until the optimal dose based on antibody response is reached
Patients are followed every 3 months
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-G01-1941 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |
| MSKCC-99062 | None | None | None |