Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019591
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2001-07-11
Brief Title:
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of Vaccination With Mutant Ras Peptide-Pulsed Dendritic Cells in the Treatment of HLA A21 Positive Patients With Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 that will kill cancer cells Combining vaccine therapy with interleukin-2 may kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have locally advanced or metastatic colorectal cancer
PURPOSE Phase III trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have locally advanced or metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Determine the frequency of immunologic response in patients with locally advanced or metastatic colorectal cancer treated with ras peptide-pulsed dendritic cell vaccine with or without interleukin-2
Determine the tumor response and survival time in patients with metastatic colorectal cancer treated with vaccine plus interleukin-2
Determine the time to progression in patients with locally advanced colorectal cancer treated with adjuvant vaccine
OUTLINE Patients are assigned to 1 of 2 treatment groups according to extent of disease Patients with prior locally advanced disease are assigned to treatment group A while those with metastatic disease are assigned to treatment group B
Group A Patients are vaccinated against influenza on day -6 Patients undergo collection of peripheral blood mononuclear cells PBMC on day -4 The PBMC are cultured with sargramostim GM-CSF and interleukin-4 for 5 days and CD40 ligand for 24 hours and then pulsed for 2 hours with the appropriate peptide to form a vaccine Patients receive ras peptide-pulsed dendritic cell vaccine IV over 5 minutes on days 1 15 29 43 and 57
Group B Patients undergo collection of PBMC and receive vaccination as in group A Patients also receive interleukin-2 subcutaneously on days 2-6 and 9-13
Treatment in both groups repeats every 2 weeks for up to 5 vaccinations in the absence of disease progression or unacceptable toxicity
Patients are followed on days 75 90 120 and 365
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study within 3 years
Determine the frequency of immunologic response in patients with locally advanced or metastatic colorectal cancer treated with ras peptide-pulsed dendritic cell vaccine with or without interleukin-2
Determine the tumor response and survival time in patients with metastatic colorectal cancer treated with vaccine plus interleukin-2
Determine the time to progression in patients with locally advanced colorectal cancer treated with adjuvant vaccine
OUTLINE Patients are assigned to 1 of 2 treatment groups according to extent of disease Patients with prior locally advanced disease are assigned to treatment group A while those with metastatic disease are assigned to treatment group B
Group A Patients are vaccinated against influenza on day -6 Patients undergo collection of peripheral blood mononuclear cells PBMC on day -4 The PBMC are cultured with sargramostim GM-CSF and interleukin-4 for 5 days and CD40 ligand for 24 hours and then pulsed for 2 hours with the appropriate peptide to form a vaccine Patients receive ras peptide-pulsed dendritic cell vaccine IV over 5 minutes on days 1 15 29 43 and 57
Group B Patients undergo collection of PBMC and receive vaccination as in group A Patients also receive interleukin-2 subcutaneously on days 2-6 and 9-13
Treatment in both groups repeats every 2 weeks for up to 5 vaccinations in the absence of disease progression or unacceptable toxicity
Patients are followed on days 75 90 120 and 365
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study within 3 years
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-T98-0034 | None | None | None |
| NCI-99-C-0023L | None | None | None |