Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389610
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2006-10-18
Brief Title:
Adjuvant GVAX Vaccine Therapy in Patients With 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 Vaccine Boosting With Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene for the Treatment of Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2023-10
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:
This is an open label phase II trial study of adjuvant GVAX pancreas vaccine in patients with pancreatic cancer
Detailed Description:
Eligible participants will receive by intradermal administration the GVAX pancreas vaccine consisting of two irradiated allogeneic pancreatic tumor cell lines transfected with the granulocyte macrophage-colony stimulating factor GM-CSF gene
There will be two cohorts of research participants
1 Participants previously vaccinated with GVAX pancreas vaccine These participants will receive booster vaccinations as a continuation of care Vaccination repeats every 6 months in the absence of disease progression or unacceptable toxicity
2 Participants who were not previously vaccinated with GVAX pancreas vaccine vaccine naive These participants received priming vaccinations once a month for 3 months followed by booster vaccinations every 6 months
There will be two cohorts of research participants
1 Participants previously vaccinated with GVAX pancreas vaccine These participants will receive booster vaccinations as a continuation of care Vaccination repeats every 6 months in the absence of disease progression or unacceptable toxicity
2 Participants who were not previously vaccinated with GVAX pancreas vaccine vaccine naive These participants received priming vaccinations once a month for 3 months followed by booster vaccinations every 6 months
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 |
|---|---|---|---|
| NA_00002731 | US NIH GrantContract | JHM IRB | httpsreporternihgovquickSearchP30CA006973 |
| P30CA006973 | NIH | None | None |
| JHOC-SKCCC-J0619 | None | None | None |