Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00079157
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2004-03-08
Brief Title:
Vaccine Plus Montanide ISA-51 and Sargramostim in Treating Patients With Stage IV Breast Cancer
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
Phase I Study Of Telomerase Peptide Vaccination For Patients With Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-02
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 Giving a vaccine with Montanide ISA-51 and sargramostim may cause a stronger immune response and kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy when given together with Montanide ISA-51 and sargramostim in treating patients with stage IV breast cancer
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy when given together with Montanide ISA-51 and sargramostim in treating patients with stage IV breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety of telomerase 540-548 peptide vaccine emulsified in Montanide ISA-51 and sargramostim GM-CSF in patients with HLA-A2-expressing stage IV breast cancer
Secondary
Compare the generation of human telomerase reverse transcriptase hTERT peptide-specific vs cytomegalovirus peptide-specific cytotoxic T-lymphocyte CTL immunity in patients treated with this regimen
Correlate the dose level of this regimen with the generation of hTERT-specific CTL immunity and the development of hTERT-specific autoimmunity in these patients
Determine the tumor response in patients treated with this regimen
OUTLINE This is a dose-escalation study of the telomerase 540-548 peptide and CMV 495 peptide portions of the vaccine
Patients receive telomerase 540-548 peptide and CMV 495 peptide as an immunological control vaccine emulsified in Montanide ISA-51 subcutaneously SC followed by sargramostim GM-CSF SC on day 1 of weeks 1 3 5 7 11 15 19 and 27 for a total of 8 vaccinations Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 5-8 patients receive escalating doses of telomerase 540-548 peptide and CMV 495 peptide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 5 or 2 of 8 patients experience dose-limiting toxicity A total of 12 patients receive treatment at the MTD
Patients are followed within 30 days and then at 6 and 12 months
PROJECTED ACCRUAL A total of 5-28 patients will be accrued for this study
Primary
Determine the safety of telomerase 540-548 peptide vaccine emulsified in Montanide ISA-51 and sargramostim GM-CSF in patients with HLA-A2-expressing stage IV breast cancer
Secondary
Compare the generation of human telomerase reverse transcriptase hTERT peptide-specific vs cytomegalovirus peptide-specific cytotoxic T-lymphocyte CTL immunity in patients treated with this regimen
Correlate the dose level of this regimen with the generation of hTERT-specific CTL immunity and the development of hTERT-specific autoimmunity in these patients
Determine the tumor response in patients treated with this regimen
OUTLINE This is a dose-escalation study of the telomerase 540-548 peptide and CMV 495 peptide portions of the vaccine
Patients receive telomerase 540-548 peptide and CMV 495 peptide as an immunological control vaccine emulsified in Montanide ISA-51 subcutaneously SC followed by sargramostim GM-CSF SC on day 1 of weeks 1 3 5 7 11 15 19 and 27 for a total of 8 vaccinations Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 5-8 patients receive escalating doses of telomerase 540-548 peptide and CMV 495 peptide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 5 or 2 of 8 patients experience dose-limiting toxicity A total of 12 patients receive treatment at the MTD
Patients are followed within 30 days and then at 6 and 12 months
PROJECTED ACCRUAL A total of 5-28 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UPCC-11102 | None | None | None |