Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008099
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2001-01-06
Brief Title:
Vaccine Therapy in Treating Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase I Dose Escalation Trial of a 100 aa Synthetic Mucin Peptide Admixed With SB-AS2 as Adjuvant in Locally Advanced and Resected Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2016-01
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 help the body build an effective immune response to kill tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with resected or locally advanced unresectable pancreatic cancer
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with resected or locally advanced unresectable pancreatic cancer
Detailed Description:
OBJECTIVES I Determine the safety and toxicity of vaccination with MUC-1 antigen and immunologic adjuvant SB AS-2 in patients with resected or locally advanced unresectable pancreatic cancer II Determine the maximum tolerated dose andor recommended phase II dose of MUC-1 antigen in this patient population III Determine the qualitative and quantitative tumor response to this treatment in these patients IV Determine the disease-free survival in resected patients progression-free survival in locally advanced unresectable patients and overall survival in all patients receiving this treatment
OUTLINE This is a dose escalation study of MUC-1 antigen Patients receive vaccination with MUC-1 antigen and immunologic adjuvant SB AS-2 intramuscularly on day 1 Treatment repeats every 3 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity Beginning 1 year after the last vaccination patients without recurrent disease may receive booster vaccines annually Cohorts of 4 to 8 patients receive escalating doses of MUC-1 antigen until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 4 or 2 of 8 patients experience dose-limiting toxicity Patients are followed at 2 weeks
PROJECTED ACCRUAL A total of 15-20 patients will be accrued for this study
OUTLINE This is a dose escalation study of MUC-1 antigen Patients receive vaccination with MUC-1 antigen and immunologic adjuvant SB AS-2 intramuscularly on day 1 Treatment repeats every 3 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity Beginning 1 year after the last vaccination patients without recurrent disease may receive booster vaccines annually Cohorts of 4 to 8 patients receive escalating doses of MUC-1 antigen until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 4 or 2 of 8 patients experience dose-limiting toxicity Patients are followed at 2 weeks
PROJECTED ACCRUAL A total of 15-20 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 |
|---|---|---|---|
| NCI-G00-1888 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068375 | REGISTRY | None | None |
| PCI-IRB-970871 | None | None | None |