Feasibility and Safety study of autologous dendritic cell immunotherapy (AGS-003-LNG) in patients with resectable non-small cell lung cancer.
Feasibility and Safety study of autologous dendritic cell immunotherapy (AGS-003-LNG) in patients with resectable non-small cell lung cancer. Non-small cell lung cancer tumor will be resected from the patient. RNA from the tumor will be amplified and subsequently electroporated into matured, autologous dendritic cells. The dendritic cells with tumor RNA will be dosed back to the patient. Study will investigate feasibility and safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
autologous dendritic cell immunotherapy
Carboplatin is an anticancer drug ("antineoplastic" or "cytotoxic") chemotherapy drug. Carboplatin is classified as an "alkylating agent."
Paclitaxel destroys cancer cells by preventing the normal breakdown of microtubules during cell division.
Cancer Research Network of Nebraska / Oncology Associates
Omaha, Nebraska, United States
Safety - Adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) V4.03
Safety of AGS-003-LNG for subjects who receive 1 or more doses of AGS-003-LNG in combination with standard platinum-doublet chemotherapy with or without radiation. Adverse events will be collected per CTCAE V4.03.
Time frame: 2 Years
Immunogenicity - Generation of Cluster of Differentiation-8 (CD8)+ Cluster of Differentiation (CD28)+ memory T-cells
Generation of CD8+CD28+ memory T-cells against tumor associated antigens in subject receiving 5 or more doses of AGS-003-LNG.
Time frame: After 5th dose of AGS-003-LNG. Within 6 months.
Efficacy - Overall survival
While the study is not powered for efficacy Overall Survival (including median and one year survival) be analyzed as an exploratory endpoints.
Time frame: 2 Years
Efficacy - Progression-free survival as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
While the study is not powered for efficacy, Progression Free Survival will be analyzed as an exploratory endpoint.
Time frame: 2 Years
Efficacy - Objective response rate. The number of patients with a Complete Response or Partial Response.
While the study is not powered for efficacy Objective Response Rate will be analyzed as an exploratory endpoint.
Time frame: 2 Years
Feasibility - Number of patients with a success in the manufacture of AGS-003-LNG.
AGS-003-LNG manufacturing success rate for non small cell lung cancer tumor RNA isolation from surgical resection.
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By inhibiting the formation of precursor purine and pyrimidine nucleotides, pemetrexed prevents the formation of DNA and RNA, which are required for the growth and survival of both normal cells and cancer cell
Binds to and causes crosslinking of DNA, which ultimately triggers apoptosis
Mechanism of action involves interference with the normal breakdown of microtubules during cell division.
Causes DNA strand breaks.
Time frame: 1 Month