Trials / Completed
CompletedNCT00004880
Vaccine Therapy in Treating Patients With Advanced Kidney Cancer
A Phase I Pilot Trial of a Multi-Antigen Loaded Dendritic Cell Vaccine for the Treatment of Advanced Renal Cell Carcinoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Jonsson Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced kidney cancer.
Detailed description
OBJECTIVES: I. Evaluate the safety of multiantigen loaded dendritic cells (DC) vaccine in patients with advanced renal cell carcinoma. II. Evaluate the immunologic response to this regimen in this patient population. III. Evaluate the clinical response to this regimen in this patient population. OUTLINE: This is a sequential cohort study. All patients undergo total nephrectomy to harvest primary tumor for vaccine preparation. Patients without primary tumor undergo surgical resection of the accessible metastatic site for vaccine preparation. Patients are assigned to 1 of 4 treatment arms. Arm I: Patients receive vaccination with irradiated autologous tumor lysate (TuLy) intradermally (ID) on day 0 followed by vaccination with multiantigen liposome loaded dendritic cells (DC) ID on days 7, 14, and 21. Arm II: Patients receive vaccinations as in arm I, except DC are pulsed with tumor cells. Arm III: Patients receive vaccination with irradiated autologous tumor lysate (TuLy) IV on day 0 followed by vaccination with multiantigen liposome loaded DC IV on days 7, 14, and 21. Arm IV: Patients receive vaccinations as in arm III, except DC are treated as in arm II. Patients are followed on days 28, 42, 70, and 112. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | dendritic cell vaccine therapy | |
| PROCEDURE | conventional surgery |
Timeline
- Start date
- 1997-06-01
- Primary completion
- 2001-04-01
- First posted
- 2004-05-20
- Last updated
- 2020-08-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00004880. Inclusion in this directory is not an endorsement.