Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128622
Status:
COMPLETED
Last Update Posted:
2012-11-12
First Post:
2005-08-08
Brief Title:
Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer
Sponsor:
H Kim Lyerly
Organization:
Duke University
Study Overview
Official Title:
A Phase I Study of Regulatory T Cell Depletion With Denileukin Diftitox Followed by Active Immunotherapy With Autologous Dendritic Cells Infected With CEA-6D Expressing Fowlpox-Tricom in Patients With Advanced or Metastatic Malignancies Expressing CEA
Status:
COMPLETED
Status Verified Date:
2012-11
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 Combinations of biological substances in denileukin diftitox may be able to carry cancer-killing substances directly to the cancer cells Vaccines made from a gene-modified virus and a persons white blood cells may help the body build an effective immune response to kill cancer cells Giving denileukin diftitox together with vaccine therapy may kill more cancer cells
PURPOSE This phase I trial is studying the side effects of giving denileukin diftitox together with vaccine therapy in treating patients with metastatic cancer that expresses carcinoembryonic antigen
PURPOSE This phase I trial is studying the side effects of giving denileukin diftitox together with vaccine therapy in treating patients with metastatic cancer that expresses carcinoembryonic antigen
Detailed Description:
OBJECTIVES
Primary
Determine the safety and feasibility of two different schedules of denileukin diftitox followed by active immunotherapy comprising autologous dendritic cells infected with recombinant fowlpox-CEA6D-TRICOM vaccine in patients with metastatic CEA-expressing malignancies
Secondary
Determine the immune response to this regimen in these patients
Determine preliminarily clinical response rate andor time to progression in patients with assessable disease treated with this regimen
OUTLINE Patients undergo leukapheresis for collection of peripheral blood mononuclear cells PBMCs PBMCs are cultured with sargramostim GM-CSF and interleukin-4 for the production of dendritic cells DC DC are mixed with recombinant fowlpox-TRICOM to produce the vaccine Patients are assigned to 1 of 2 cohorts according to timing of study enrollment
Cohort 1 Patients receive denileukin diftitox IV over at least 15 minutes once in week 0 and vaccine therapy comprising autologous DC infected with recombinant fowlpox-CEA 6D-TRICOM vaccine intradermally and subcutaneously once in weeks 0 beginning 4 days after the denileukin diftitox infusion 3 6 and 9 If 2 of 6 patients experience dose-limiting toxicity a second cohort of patients is enrolled
Cohort 2 Patients receive denileukin diftitox as in cohort 1 once in weeks 0 3 6 and 9 and vaccine as in cohort 1
In both cohorts treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed annually for up to 15 years
PROJECTED ACCRUAL A total of 6-12 patients 6 per cohort will be accrued for this study
Primary
Determine the safety and feasibility of two different schedules of denileukin diftitox followed by active immunotherapy comprising autologous dendritic cells infected with recombinant fowlpox-CEA6D-TRICOM vaccine in patients with metastatic CEA-expressing malignancies
Secondary
Determine the immune response to this regimen in these patients
Determine preliminarily clinical response rate andor time to progression in patients with assessable disease treated with this regimen
OUTLINE Patients undergo leukapheresis for collection of peripheral blood mononuclear cells PBMCs PBMCs are cultured with sargramostim GM-CSF and interleukin-4 for the production of dendritic cells DC DC are mixed with recombinant fowlpox-TRICOM to produce the vaccine Patients are assigned to 1 of 2 cohorts according to timing of study enrollment
Cohort 1 Patients receive denileukin diftitox IV over at least 15 minutes once in week 0 and vaccine therapy comprising autologous DC infected with recombinant fowlpox-CEA 6D-TRICOM vaccine intradermally and subcutaneously once in weeks 0 beginning 4 days after the denileukin diftitox infusion 3 6 and 9 If 2 of 6 patients experience dose-limiting toxicity a second cohort of patients is enrolled
Cohort 2 Patients receive denileukin diftitox as in cohort 1 once in weeks 0 3 6 and 9 and vaccine as in cohort 1
In both cohorts treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed annually for up to 15 years
PROJECTED ACCRUAL A total of 6-12 patients 6 per cohort 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-7042 | None | None | None |
| DUMC-NCI-7042 | None | None | None |