Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093522
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2004-10-06
Brief Title:
Vaccine Therapy With or Without Fludarabine in Treating Patients With Stage IV Kidney Cancer
Sponsor:
St Lukes Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Pilot Study of Tumor-Loaded Dendritic Cells Alone or Following a Non-Myeloablative Conditioning Regimen in Patients With Metastatic Renal Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Vaccines made from a persons tumor cells and white blood cells may make the body build an immune response to kill tumor cells Drugs used in chemotherapy such as fludarabine work in different ways to stop tumor cells from dividing so they stop growing or die Combining vaccine therapy with fludarabine may kill more tumor cells
PURPOSE This randomized phase II trial is studying vaccine therapy and fludarabine to see how well they work compared to vaccine therapy alone in treating patients with stage IV kidney cancer
PURPOSE This randomized phase II trial is studying vaccine therapy and fludarabine to see how well they work compared to vaccine therapy alone in treating patients with stage IV kidney cancer
Detailed Description:
OBJECTIVES
Primary
Compare the safety of vaccination comprising autologous dendritic cells loaded with autologous tumor lysate and keyhole limpet hemocyanin with vs without non-myeloablative fludarabine in patients with stage IV renal cell carcinoma
Compare preliminarily the efficacy of these regimens in these patients
Compare the overall survival of patients treated with these regimens
Secondary
Determine whether this vaccine induces tumor-reactive peripheral T-cell responses or delayed-type hypersensitivity in these patients
OUTLINE This is a pilot randomized study Patients are randomized to 1 of 2 treatment arms
All patients undergo surgery to remove tumor at metastatic sites to generate autologous tumor lysate Patients then undergo leukapheresis to obtain peripheral blood mononuclear cells for the generation of dendritic cells DC The DC are then exposed to autologous tumor lysate and keyhole limpet hemocyanin KLH
Arm I Three weeks after leukapheresis patients receive vaccination comprising DC loaded with autologous tumor lysate and KLH DC vaccine intradermally once every 14 days for a total of 4 injections in the absence of disease progression or unacceptable toxicity
Arm II Two weeks after leukapheresis patients receive fludarabine IV over 15-30 minutes once daily for 3 days Beginning approximately 5 weeks after leukapheresis patients also receive DC vaccine as in arm I
Patients are followed at 1 3 and 7-9 weeks at 4 6 9 and 12 months and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 28 patients 14 per treatment arm will be accrued for this study within 2-3 years
Primary
Compare the safety of vaccination comprising autologous dendritic cells loaded with autologous tumor lysate and keyhole limpet hemocyanin with vs without non-myeloablative fludarabine in patients with stage IV renal cell carcinoma
Compare preliminarily the efficacy of these regimens in these patients
Compare the overall survival of patients treated with these regimens
Secondary
Determine whether this vaccine induces tumor-reactive peripheral T-cell responses or delayed-type hypersensitivity in these patients
OUTLINE This is a pilot randomized study Patients are randomized to 1 of 2 treatment arms
All patients undergo surgery to remove tumor at metastatic sites to generate autologous tumor lysate Patients then undergo leukapheresis to obtain peripheral blood mononuclear cells for the generation of dendritic cells DC The DC are then exposed to autologous tumor lysate and keyhole limpet hemocyanin KLH
Arm I Three weeks after leukapheresis patients receive vaccination comprising DC loaded with autologous tumor lysate and KLH DC vaccine intradermally once every 14 days for a total of 4 injections in the absence of disease progression or unacceptable toxicity
Arm II Two weeks after leukapheresis patients receive fludarabine IV over 15-30 minutes once daily for 3 days Beginning approximately 5 weeks after leukapheresis patients also receive DC vaccine as in arm I
Patients are followed at 1 3 and 7-9 weeks at 4 6 9 and 12 months and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 28 patients 14 per treatment arm will be accrued for this study within 2-3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STLMC-L-03-138 | None | None | None |
| STLMC-IMM-03-05 | None | None | None |