Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305760
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2006-03-21
Brief Title:
Vaccine Therapy Cyclophosphamide and Cetuximab in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Safety and Efficacy Trial of Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene in Combination With Erbitux Cetuximab for the Treatment of Advanced Pancreatic Adenocarcinoma
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 made from gene-modified tumor cells may help the body build an immune response to kill tumor cells Drugs used in chemotherapy such as cyclophosphamide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as cetuximab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving vaccine therapy together with cyclophosphamide and cetuximab may kill more tumor cells
PURPOSE This phase II trial is studying how well vaccine therapy works when given together with cyclophosphamide and cetuximab in treating patients with metastatic or locally advanced pancreatic cancer
PURPOSE This phase II trial is studying how well vaccine therapy works when given together with cyclophosphamide and cetuximab in treating patients with metastatic or locally advanced pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety of pancreatic tumor vaccine cyclophosphamide and cetuximab in patients with metastatic or locally advanced adenocarcinoma of the pancreas
Secondary
Determine the overall progression-free and event-free survival of patients treated with this regimen
Correlate specific in vivo parameters of immune response eg mesothelin prostate stem cell antigen PSCA mutated k-ras-specific T-cell responses with clinical response in patients treated with this regimen
Correlate downstream targets of epidermal growth factor receptor EGFR signaling eg intratumor expression of Akt Stat 3 and 5 mesothelin mutated k-ras and PSCA with inhibition by cetuximab in patients treated with this regimen
Correlate inhibition of EGFR signaling eg Stat 3 and 5 with improved specific mesothelin PSCA and mutated k-ras-specific T-cell responses in patients treated with this regimen
OUTLINE This is an open-label study
Patients receive cyclophosphamide IV on day 0 sargramostim plasmid DNA pancreatic tumor vaccine intradermally on day 1 and cetuximab IV over 1-2 hours on days 1 8 and 15 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients undergo blood collection and tumor biopsies periodically during study for biomarker correlative studies
At the completion of study treatment patients are followed at 3 weeks and then every 4 weeks for 16 weeks
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Primary
Determine the safety of pancreatic tumor vaccine cyclophosphamide and cetuximab in patients with metastatic or locally advanced adenocarcinoma of the pancreas
Secondary
Determine the overall progression-free and event-free survival of patients treated with this regimen
Correlate specific in vivo parameters of immune response eg mesothelin prostate stem cell antigen PSCA mutated k-ras-specific T-cell responses with clinical response in patients treated with this regimen
Correlate downstream targets of epidermal growth factor receptor EGFR signaling eg intratumor expression of Akt Stat 3 and 5 mesothelin mutated k-ras and PSCA with inhibition by cetuximab in patients treated with this regimen
Correlate inhibition of EGFR signaling eg Stat 3 and 5 with improved specific mesothelin PSCA and mutated k-ras-specific T-cell responses in patients treated with this regimen
OUTLINE This is an open-label study
Patients receive cyclophosphamide IV on day 0 sargramostim plasmid DNA pancreatic tumor vaccine intradermally on day 1 and cetuximab IV over 1-2 hours on days 1 8 and 15 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients undergo blood collection and tumor biopsies periodically during study for biomarker correlative studies
At the completion of study treatment patients are followed at 3 weeks and then every 4 weeks for 16 weeks
PROJECTED ACCRUAL A total of 60 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 |
|---|---|---|---|
| BMS-CA225247 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| P30CA006973 | NIH | None | None |