Trials / Completed
CompletedNCT00128622
Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- H. Kim Lyerly · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 person's 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.
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-CEA(6D)-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 and/or 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.
Conditions
- Breast Cancer
- Colorectal Cancer
- Lung Cancer
- Pancreatic Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | denileukin diftitox | |
| BIOLOGICAL | recombinant fowlpox-CEA(6D)/TRICOM vaccine | |
| BIOLOGICAL | therapeutic autologous dendritic cells |
Timeline
- Start date
- 2005-09-01
- Primary completion
- 2007-03-01
- Completion
- 2009-05-01
- First posted
- 2005-08-10
- Last updated
- 2012-11-12
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00128622. Inclusion in this directory is not an endorsement.