Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006041
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-07-05
Brief Title:
Vaccine Therapy in Treating Patients With Ovarian Fallopian Tube or Peritoneal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Vaccination of Patients Who Have Ovarian Fallopian Tube or Peritoneal Cancer With Glycosylated MUC-1-KLH Conjugate Plus the Immunological Adjuvant QS-21
Status:
COMPLETED
Status Verified Date:
2013-06
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 made from a persons cancer cells may make the body build an immune response to kill the tumor cells
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian fallopian tube or peritoneal cancer
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian fallopian tube or peritoneal cancer
Detailed Description:
OBJECTIVES I Determine the safety of immunization with glycosylated MUC-1-KLH vaccine plus adjuvant QS21 in patients with ovarian fallopian tube or peritoneal epithelial cancer II Determine the dose of this treatment regimen for optimal antibody response in these patients III Determine the effect of immunization with this treatment regimen on the T-cell response in these patients
OUTLINE This is a dose escalation study of glycosylated MUC-1-KLH vaccine Patients receive glycosylated MUC-1-KLH vaccine and QS21 subcutaneously once a week on weeks 1-3 7 and 19 Cohorts of 6 patients receive escalating doses of glycosylated MUC-1-KLH until the dose for optimal antibody response without unacceptable toxicity is determined Patients are followed at 2 and 12 weeks and then every 3 months thereafter as long as detectable immunity against MUC-1 persists
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study
OUTLINE This is a dose escalation study of glycosylated MUC-1-KLH vaccine Patients receive glycosylated MUC-1-KLH vaccine and QS21 subcutaneously once a week on weeks 1-3 7 and 19 Cohorts of 6 patients receive escalating doses of glycosylated MUC-1-KLH until the dose for optimal antibody response without unacceptable toxicity is determined Patients are followed at 2 and 12 weeks and then every 3 months thereafter as long as detectable immunity against MUC-1 persists
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study
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-H00-0060 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068056 | REGISTRY | None | None |