Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084383
Status:
COMPLETED
Last Update Posted:
2013-07-22
First Post:
2004-06-10
Brief Title:
Vaccine Therapy Combined With Adjuvant Chemoradiotherapy in Treating Patients With Resected Stage I or Stage II Adenocarcinoma Cancer of the Pancreas
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 Adjuvant Chemoradiotherapy for the Treatment of Adenocarcinoma of the Pancreas
Status:
COMPLETED
Status Verified Date:
2013-07
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:
RATIONALE Vaccines made from gene-modified pancreatic cancer cells may make the body build an immune response to kill tumor cells Drugs used in chemotherapy such as fluorouracil work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Giving vaccine therapy together with chemotherapy and radiation therapy after surgery may kill any remaining tumor cells
PURPOSE This phase II trial is studying how well giving vaccine therapy together with adjuvant chemoradiotherapy works in treating patients with resected stage I or stage II adenocarcinoma cancer of the pancreas
PURPOSE This phase II trial is studying how well giving vaccine therapy together with adjuvant chemoradiotherapy works in treating patients with resected stage I or stage II adenocarcinoma cancer of the pancreas
Detailed Description:
OBJECTIVES
Primary
Determine overall and disease-free survival of patients with resected stage I or II adenocarcinoma of the pancreas treated with adjuvant chemoradiotherapy in combination with GVAX pancreatic cancer vaccine
Secondary
Correlate specific in vivo parameters of immune response post-vaccination delayed-type hypersensitivity reactions to autologous tumor mesothelin-specific T-cell response and the degree of local eosinophil macrophage and T-cell infiltration at the vaccine site with clinical responses in patients treated with this regimen
Determine the toxic effects associated with intradermal injections of this vaccine in these patients
OUTLINE This is an open-label study
Post surgery vaccination Within 8-10 weeks after pancreaticoduodenectomy patients receive GVAX pancreatic cancer vaccine intradermally ID on day 0
Adjuvant chemoradiotherapy Within 16-28 days after the first vaccination patients receive fluorouracil 5-FU IV continuously for 3 weeks Approximately 1-2 weeks after completion of 5-FU patients receive chemoradiotherapy comprising radiotherapy daily and 5-FU IV continuously for 26-28 weeks Approximately 3-5 weeks after completion of chemoradiotherapy patients receive 5-FU IV continuously for 4 weeks 5-FU repeats every 6 weeks for 2 courses
Post chemoradiotherapy vaccination Within 4-8 weeks after the completion of chemoradiotherapy patients receive GVAX pancreatic cancer vaccine ID on days 0 28 56 and 196
Treatment continues in the absence of unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Primary
Determine overall and disease-free survival of patients with resected stage I or II adenocarcinoma of the pancreas treated with adjuvant chemoradiotherapy in combination with GVAX pancreatic cancer vaccine
Secondary
Correlate specific in vivo parameters of immune response post-vaccination delayed-type hypersensitivity reactions to autologous tumor mesothelin-specific T-cell response and the degree of local eosinophil macrophage and T-cell infiltration at the vaccine site with clinical responses in patients treated with this regimen
Determine the toxic effects associated with intradermal injections of this vaccine in these patients
OUTLINE This is an open-label study
Post surgery vaccination Within 8-10 weeks after pancreaticoduodenectomy patients receive GVAX pancreatic cancer vaccine intradermally ID on day 0
Adjuvant chemoradiotherapy Within 16-28 days after the first vaccination patients receive fluorouracil 5-FU IV continuously for 3 weeks Approximately 1-2 weeks after completion of 5-FU patients receive chemoradiotherapy comprising radiotherapy daily and 5-FU IV continuously for 26-28 weeks Approximately 3-5 weeks after completion of chemoradiotherapy patients receive 5-FU IV continuously for 4 weeks 5-FU repeats every 6 weeks for 2 courses
Post chemoradiotherapy vaccination Within 4-8 weeks after the completion of chemoradiotherapy patients receive GVAX pancreatic cancer vaccine ID on days 0 28 56 and 196
Treatment continues in the absence of unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months thereafter
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 |
|---|---|---|---|
| JHOC-J9988 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| R01CA088058 | NIH | None | None |
| P30CA006973 | NIH | None | None |