Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer
- Conditions
- Breast CancerColorectal CancerLung CancerPancreatic CancerUnspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Biological: denileukin diftitoxBiological: recombinant fowlpox-CEA(6D)/TRICOM vaccineBiological: therapeutic autologous dendritic cells
- Registration Number
- NCT00128622
- Lead Sponsor
- H. Kim Lyerly
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Denileukin Diftitox plus vaccine denileukin diftitox This is a single arm Phase I safety study. Denileukin Diftitox plus vaccine recombinant fowlpox-CEA(6D)/TRICOM vaccine This is a single arm Phase I safety study. Denileukin Diftitox plus vaccine therapeutic autologous dendritic cells This is a single arm Phase I safety study.
- Primary Outcome Measures
Name Time Method Safety as measured by rate of adverse events during study drug treatment 3 months
- Secondary Outcome Measures
Name Time Method Rate of immune response as measured by ELISPot at week 10 3 months
Trial Locations
- Locations (2)
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States