Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014131
Status:
TERMINATED
Last Update Posted:
2023-10-04
First Post:
2001-04-10
Brief Title:
Vaccine Therapy in Treating Patients With Kidney Cancer
Sponsor:
Lisata Therapeutics Inc
Organization:
Lisata Therapeutics Inc
Study Overview
Official Title:
Vaccine Biotherapy Of Cancer Autologous Tumor Cells And Dendritic Cells As Active Specific Immunotherapy In Patients With Stage IV Renal Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
change in corporate priorities
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 patients white blood cells and tumor cells may make the body build an immune response to kill tumor cells
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients who have recurrent or stage III or stage IV kidney cancer
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients who have recurrent or stage III or stage IV kidney cancer
Detailed Description:
OBJECTIVES
Determine the safety of immunization with in vitro-treated autologous tumor cells and dendritic cells with sargramostim GM-CSF in patients with stage III or IV or recurrent renal cell cancer
Determine the frequency of conversion of delayed tumor hypersensitivity tests in these patients treated with this regimen
Determine the progression-free and overall survival of these patients treated with this regimen
Determine the objective tumor response rate in patients who still have measurable disease at the time they are treated with this regimen
OUTLINE Patients are stratified according to measurable disease at the time vaccine therapy is initiated yes vs no
Patients undergo tumor cell harvest Patients with multiple persistent sites of metastatic disease following harvest receive systemic therapy biologic therapy andor chemotherapy during tumor cell line expansion Over 2-4 months the tumor cell line is expanded treated with interferon gamma and irradiated
Patients undergo leukapheresis to obtain peripheral blood mononuclear cells PBMC The PBMC are incubated over 7 days with sargramostim GM-CSF and interleukin-4 to produce dendritic cells DC The DC are incubated over 2-3 days with the irradiated tumor cells from the autologous tumor cell line for antigen loading of the DC
Patients undergo delayed tumor hypersensitivity testing 1 week prior to vaccination and again at week 4 Patients receive vaccine therapy comprising autologous treated tumor cells and DC suspended in GM-CSF subcutaneously weekly for 3 weeks Vaccine therapy continues monthly for 5 months in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year and then every 3 months for 4 years
PROJECTED ACCRUAL A total of 80 patients 40 per stratum will be accrued for this study
Determine the safety of immunization with in vitro-treated autologous tumor cells and dendritic cells with sargramostim GM-CSF in patients with stage III or IV or recurrent renal cell cancer
Determine the frequency of conversion of delayed tumor hypersensitivity tests in these patients treated with this regimen
Determine the progression-free and overall survival of these patients treated with this regimen
Determine the objective tumor response rate in patients who still have measurable disease at the time they are treated with this regimen
OUTLINE Patients are stratified according to measurable disease at the time vaccine therapy is initiated yes vs no
Patients undergo tumor cell harvest Patients with multiple persistent sites of metastatic disease following harvest receive systemic therapy biologic therapy andor chemotherapy during tumor cell line expansion Over 2-4 months the tumor cell line is expanded treated with interferon gamma and irradiated
Patients undergo leukapheresis to obtain peripheral blood mononuclear cells PBMC The PBMC are incubated over 7 days with sargramostim GM-CSF and interleukin-4 to produce dendritic cells DC The DC are incubated over 2-3 days with the irradiated tumor cells from the autologous tumor cell line for antigen loading of the DC
Patients undergo delayed tumor hypersensitivity testing 1 week prior to vaccination and again at week 4 Patients receive vaccine therapy comprising autologous treated tumor cells and DC suspended in GM-CSF subcutaneously weekly for 3 weeks Vaccine therapy continues monthly for 5 months in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year and then every 3 months for 4 years
PROJECTED ACCRUAL A total of 80 patients 40 per stratum 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-V01-1647 | OTHER | National Cancer Institute | None |
| HOAG-VACCINE-RN | OTHER | None | None |