Ignite Creation Date:
2024-05-05 @ 9:08 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00819806
Status:
COMPLETED
Last Update Posted:
2017-07-31
First Post:
2009-01-07
Brief Title:
CpG 7909Montanide ISA 720 With or Without Cyclophosphamide in Combination Either With NY-ESO-1-derived Peptides or the NY-ESO-1 Protein for NY-ESO-1-expressing Tumors
Sponsor:
Hassane M Zarour MD
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase I Study of Vaccination With CpG 7909 and Montanide ISA 720 With or Without Cyclophosphamide in Combination Either With NY-ESO-1-derived Peptides or the NY-ESO-1 Protein in Patients With NY-ESO-1-expressing Tumors
Status:
COMPLETED
Status Verified Date:
2017-07
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:
Subjects will receive immunizations every other week for 8 immunizations prior to clinical and immunological evaluations Patients will then receive immunizations every month up to one year Cyclophosphamide will be administered intravenously 3 days prior to the first immunization 3rd 5th 7th 9th and subsequent monthly immunizations Women and men 18 years of age with refractory metastatic malignancies that express NY-ESO-1 by RT-PCR or immunohistochemistry Alternatively patients may be elected on the basis of serum anti-NY-ESO--antibodies as detected by ELISA
Primary Objective To evaluate the toxicity profile of the regimens described in Section 16
Secondary Objective To detect and quantitate immune responses induced by the proposed peptide vaccine or protein vaccine in association with CpG 7909 and cyclophosphamide This endpoint will be assessed by an IFN-y ELISPOT assay of NY-ESO-1-specific tumor-reactive CD8 T cells We also will look for NY-ESO-1 tetramer CD8 T cells Delayed-type Hypersensitivity DTH and NY-ESO-1-specific CD4 T cell responses with ELISPOT assays and cytokine-release-assays
Tertiary Objectives To evaluate tumor response in terms of clinical tumor regression and progression-free interval To evaluate the survival of patients treated with the regimens described in Section 16
The first 3 patients will be assigned treatment A All three patients will be treated and observed for one month If no DLTs are observed in the first 3 patients accrual to arm A will be put on hold and accrual will continue with Arm B However if 1 DLT is observed in Arm A up to 3 additional patients will be treated on Arm A until either 2 DLTs have been observed or 6 patients have been treated with just 1 DLT among them If 2 DLTs are observed in Arm A the study will terminate and all treatments will be deemed intolerable The same principles apply to the cohorts treated on B-E if the number of DLTs after one month of treatment is zero accrual proceeds to the next treatment group if it is 1 accrual continues with the same treatment for up to 3 additional patients if it is 2 no patients will be treated on the remaining treatment arms
Primary Objective To evaluate the toxicity profile of the regimens described in Section 16
Secondary Objective To detect and quantitate immune responses induced by the proposed peptide vaccine or protein vaccine in association with CpG 7909 and cyclophosphamide This endpoint will be assessed by an IFN-y ELISPOT assay of NY-ESO-1-specific tumor-reactive CD8 T cells We also will look for NY-ESO-1 tetramer CD8 T cells Delayed-type Hypersensitivity DTH and NY-ESO-1-specific CD4 T cell responses with ELISPOT assays and cytokine-release-assays
Tertiary Objectives To evaluate tumor response in terms of clinical tumor regression and progression-free interval To evaluate the survival of patients treated with the regimens described in Section 16
The first 3 patients will be assigned treatment A All three patients will be treated and observed for one month If no DLTs are observed in the first 3 patients accrual to arm A will be put on hold and accrual will continue with Arm B However if 1 DLT is observed in Arm A up to 3 additional patients will be treated on Arm A until either 2 DLTs have been observed or 6 patients have been treated with just 1 DLT among them If 2 DLTs are observed in Arm A the study will terminate and all treatments will be deemed intolerable The same principles apply to the cohorts treated on B-E if the number of DLTs after one month of treatment is zero accrual proceeds to the next treatment group if it is 1 accrual continues with the same treatment for up to 3 additional patients if it is 2 no patients will be treated on the remaining treatment arms
Detailed Description:
None
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 |
|---|---|---|---|
| 1R01CA112198-01 | NIH | None | httpsreporternihgovquickSearch1R01CA112198-01 |