Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031564
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2002-03-08
Brief Title:
Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2 for Patients With Stage IV Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
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 by inserting a laboratory-treated gene into a persons tumor cells may make the body build an immune response to kill tumor cells Interleukin-2 may stimulate a persons white blood cells to kill cancer cells Combining vaccine therapy with interleukin-2 may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have stage IV kidney cancer
PURPOSE Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have stage IV kidney cancer
Detailed Description:
OBJECTIVES
Determine the percentage of patients with stage IV renal cell carcinoma with a reduction in tumor size after treatment with B7-1 gene-modified autologous tumor cell vaccine and interleukin-2
Determine the immunogenicity of this regimen in these patients
Determine the overall survival of patients treated with this regimen
Determine the local and systemic toxicity of this regimen in these patients
OUTLINE Tumor tissue for vaccine preparation is obtained when patients undergo palliative surgical resection of primary tumor or therapeutic resection of metastasis
At approximately 3-6 weeks after surgery patients receive B7-1 gene-modified autologous tumor cell vaccine subcutaneously SC once on days 1 29 and 57 At 6 weeks after the first vaccination patients receive interleukin-2 IL-2 SC five days a week for 6 weeks days 43-82 Patients with stable or responding disease after day 106 may receive additional vaccinations in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 weeks after the last dose of IL-2
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
Determine the percentage of patients with stage IV renal cell carcinoma with a reduction in tumor size after treatment with B7-1 gene-modified autologous tumor cell vaccine and interleukin-2
Determine the immunogenicity of this regimen in these patients
Determine the overall survival of patients treated with this regimen
Determine the local and systemic toxicity of this regimen in these patients
OUTLINE Tumor tissue for vaccine preparation is obtained when patients undergo palliative surgical resection of primary tumor or therapeutic resection of metastasis
At approximately 3-6 weeks after surgery patients receive B7-1 gene-modified autologous tumor cell vaccine subcutaneously SC once on days 1 29 and 57 At 6 weeks after the first vaccination patients receive interleukin-2 IL-2 SC five days a week for 6 weeks days 43-82 Patients with stable or responding disease after day 106 may receive additional vaccinations in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 weeks after the last dose of IL-2
PROJECTED ACCRUAL Approximately 30 patients 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 |
|---|---|---|---|
| 0001386 | OTHER | OBA | None |
| NCI-5090 | OTHER | None | None |
| NCI-G00-1872 | OTHER | None | None |