Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006387
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2000-10-04
Brief Title:
Vaccine Therapy Plus QS21 in Treating Patients With Advanced Pancreatic or Colorectal Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Phase I Study of RAS Peptide Vaccination in Patients With Advanced Pancreatic or Colorectal Adenocarcinoma
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 may make the body build an immune response to kill tumor cells QS21 may improve the ability of the immune system to respond to disease Combining vaccine therapy with QS21 may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of vaccine therapy plus QS21 in treating patients who have advanced pancreatic or colorectal cancer
PURPOSE Phase I trial to study the effectiveness of vaccine therapy plus QS21 in treating patients who have advanced pancreatic or colorectal cancer
Detailed Description:
OBJECTIVES I Determine the toxicity of ras peptide cancer vaccine plus immunological adjuvant QS21 in patients with advanced pancreatic or colorectal adenocarcinoma II Determine the immunologic effects of this treatment regimen in these patients III Determine the antitumor effect of this treatment regimen in these patients
OUTLINE This is a dose escalation study of ras peptide cancer vaccine Patients receive ras peptide cancer vaccine mixed with immunological adjuvant QS21 subcutaneously monthly for 4 doses every 2 months for 4 doses every 4 months for 3 doses every 6 months for 2 doses and then annually thereafter in the absence of unacceptable toxicity Cohorts of 3 to 6 patients receive escalating doses of ras peptide cancer vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 4 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 15-20 patients will be accrued for this study within 30 months
OUTLINE This is a dose escalation study of ras peptide cancer vaccine Patients receive ras peptide cancer vaccine mixed with immunological adjuvant QS21 subcutaneously monthly for 4 doses every 2 months for 4 doses every 4 months for 3 doses every 6 months for 2 doses and then annually thereafter in the absence of unacceptable toxicity Cohorts of 3 to 6 patients receive escalating doses of ras peptide cancer vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 4 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 15-20 patients will be accrued for this study within 30 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 |
|---|---|---|---|
| NCI-T97-0051 | OTHER_GRANT | NCI | None |