Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT00601094
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2008-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Phase I Trial of CCL21 Gene Modified Dendritic Cells In Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2017-10
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 gene-modified virus may help 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 with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Detailed Description:
OBJECTIVES:
Primary
* To determine the safety, toxicity, and maximum tolerated dose (MTD) of autologous dendritic cell-adenovirus CCL21 vaccine administered as an intratumoral injection in treating patients with stage IIIB, IV, or recurrent non-small cell lung cancer.
Secondary
* To determine the biologic and clinical responses to therapy.
* To determine treatment-related toxicity using the NCI Common Toxicity Criteria.
* To identify the MTD.
* To monitor patients for evidence of autologous dendritic cell-adenovirus CCL21 vaccine-induced cytokines and antigen-specific immune responses.
* To detect immune responses to tumor-associated antigens and vector.
* To assess patients for objective signs of tumor regression (RECIST Criteria).
OUTLINE: This is a dose-escalation study of autologous dendritic cell-adenovirus CCL21 vaccine.
Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Adenovirus carrying the CCL21 gene is added to the dendritic cells to make the vaccine. Approximately 2 weeks after leukapheresis, patients receive an intratumoral injection of autologous dendritic cell-adenovirus CCL21 vaccine under CT-guidance or by bronchoscopy on days 0 and 7. Patients demonstrating a clinical response are eligible to receive a second round of gene transfer at their discretion and in consultation with the FDA.
Cohorts of 3 patients receive escalating doses of autologous dendritic cell-adenovirus CCL21 vaccine until the maximum tolerated dose (MTD) is determined. An additional 12 patients are treated at the MTD.
Patients undergo blood sample collection at baseline and then on days 0, 7, 14, 28, and 56 for safety and immunological studies. Blood samples are analyzed for mycoplasma by PCR; dendritic cell phenotype by flow cytometry; detection of adenovirus CCL21 by nested PCR; and adenoviral antibodies by ELISA. Patients also undergo tissue aspirate or biopsy on days 0 and 7 (during bronchoscopy or CT-guided procedure). Tissue samples are analyzed for immune-modulating cytokines (i.e., IFNγ, CXCL9, and CXCL10) by quantitative RT-PCR; detection of tumor infiltrating leukocytes by immunohistochemistry; CD83+ DC, CXCR3, CCR7, CCL21 and CD3+ T-cells, CD4, and CD8 by flow cytometry; determination of tumor expression of tumor-associated antigen by RT-PCR; and evaluation of immune modulation by ELISPOT assays.
After completion of study treatment, patients are followed periodically.
Primary
* To determine the safety, toxicity, and maximum tolerated dose (MTD) of autologous dendritic cell-adenovirus CCL21 vaccine administered as an intratumoral injection in treating patients with stage IIIB, IV, or recurrent non-small cell lung cancer.
Secondary
* To determine the biologic and clinical responses to therapy.
* To determine treatment-related toxicity using the NCI Common Toxicity Criteria.
* To identify the MTD.
* To monitor patients for evidence of autologous dendritic cell-adenovirus CCL21 vaccine-induced cytokines and antigen-specific immune responses.
* To detect immune responses to tumor-associated antigens and vector.
* To assess patients for objective signs of tumor regression (RECIST Criteria).
OUTLINE: This is a dose-escalation study of autologous dendritic cell-adenovirus CCL21 vaccine.
Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Adenovirus carrying the CCL21 gene is added to the dendritic cells to make the vaccine. Approximately 2 weeks after leukapheresis, patients receive an intratumoral injection of autologous dendritic cell-adenovirus CCL21 vaccine under CT-guidance or by bronchoscopy on days 0 and 7. Patients demonstrating a clinical response are eligible to receive a second round of gene transfer at their discretion and in consultation with the FDA.
Cohorts of 3 patients receive escalating doses of autologous dendritic cell-adenovirus CCL21 vaccine until the maximum tolerated dose (MTD) is determined. An additional 12 patients are treated at the MTD.
Patients undergo blood sample collection at baseline and then on days 0, 7, 14, 28, and 56 for safety and immunological studies. Blood samples are analyzed for mycoplasma by PCR; dendritic cell phenotype by flow cytometry; detection of adenovirus CCL21 by nested PCR; and adenoviral antibodies by ELISA. Patients also undergo tissue aspirate or biopsy on days 0 and 7 (during bronchoscopy or CT-guided procedure). Tissue samples are analyzed for immune-modulating cytokines (i.e., IFNγ, CXCL9, and CXCL10) by quantitative RT-PCR; detection of tumor infiltrating leukocytes by immunohistochemistry; CD83+ DC, CXCR3, CCR7, CCL21 and CD3+ T-cells, CD4, and CD8 by flow cytometry; determination of tumor expression of tumor-associated antigen by RT-PCR; and evaluation of immune modulation by ELISPOT assays.
After completion of study treatment, patients are followed periodically.
Study Oversight
Has Oversight DMC:
True
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?: