Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098917
Status:
TERMINATED
Last Update Posted:
2008-01-28
First Post:
2004-12-08
Brief Title:
Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Stage IB Stage II or Stage IIIA Non-Small Cell Lung Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Clinical Trial of Mature Autologous Dendritic Cells Loaded With Irradiated Autologous Tumor Cells for the Treatment of Non-Small Cell Lung Cancer NSCLC
Status:
TERMINATED
Status Verified Date:
2007-04
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 from a persons tumor cells and white blood cells may make the body build an effective immune response to kill tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who are undergoing surgery for stage IB stage II or stage IIIA non-small cell lung cancer
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who are undergoing surgery for stage IB stage II or stage IIIA non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of adjuvant autologous dendritic cells loaded with irradiated autologous tumor cells in patients with stage IB-IIIA non-small cell lung cancer undergoing resection
Determine the safety and tolerability of this vaccine in these patients
Secondary
Determine the feasibility of this vaccine in these patients
Determine vaccine-specific and antitumor immunity in patients treated with this vaccine
OUTLINE This is a dose-escalation study
Patients undergo leukaphersis to isolate peripheral blood mononuclear cells PBMC PBMC are expanded ex vivo to generate monocyte-derived dendritic cells DC Autologous tumor cells are harvested and purified at the time of surgical resection DC are then loaded with irradiated autologous tumor cells
Within 4-8 weeks after surgical resection patients receive autologous DC loaded with irradiated autologous tumor cells intradermally on approximately days 1 30 and 60 in the absence of unacceptable toxicity
Cohorts of 6-9 patients receive escalating doses of vaccine until the maximum tolerated dose MTD is determined If 2 of 9 patients in the first cohort experience dose-limiting toxicity that dose level is considered the MTD
Patients are followed at approximately 1 and 4 months and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 12-15 patients will be accrued for this study within 18 months
Primary
Determine the maximum tolerated dose of adjuvant autologous dendritic cells loaded with irradiated autologous tumor cells in patients with stage IB-IIIA non-small cell lung cancer undergoing resection
Determine the safety and tolerability of this vaccine in these patients
Secondary
Determine the feasibility of this vaccine in these patients
Determine vaccine-specific and antitumor immunity in patients treated with this vaccine
OUTLINE This is a dose-escalation study
Patients undergo leukaphersis to isolate peripheral blood mononuclear cells PBMC PBMC are expanded ex vivo to generate monocyte-derived dendritic cells DC Autologous tumor cells are harvested and purified at the time of surgical resection DC are then loaded with irradiated autologous tumor cells
Within 4-8 weeks after surgical resection patients receive autologous DC loaded with irradiated autologous tumor cells intradermally on approximately days 1 30 and 60 in the absence of unacceptable toxicity
Cohorts of 6-9 patients receive escalating doses of vaccine until the maximum tolerated dose MTD is determined If 2 of 9 patients in the first cohort experience dose-limiting toxicity that dose level is considered the MTD
Patients are followed at approximately 1 and 4 months and then every 6 months for 4 years
PROJECTED ACCRUAL A total of 12-15 patients will be accrued for this study within 18 months
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 |
|---|---|---|---|
| NCI-6766 | None | None | None |
| UCLA-0406031-01 | None | None | None |