Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Vaccines

Cyclophosphamide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

* Standard of care surgery
* Apheresis (between Day -28 and Day -7) approximately 12 weeks after surgery
* Cyclophosphamide 300 mg/m\^2 intravenously (Day -4)
* Personalized vaccine (Day 1)
* Booster dose of personalized vaccine (Day 43)
* Booster dose of personalized vaccine (Day 85)

Standard of care surgery

Apheresis

Personalized mature dendritic cell vaccine

Ramaswamy Govindan, M.D.

The purpose of this research study is to study the safety and immune response of people who receive a personalized dendritic cell vaccine with the intention of stimulating the immune system to react to lung cancer cells.

Tumor vaccines represent a promising area of clinical investigation in solid tumors based on evidence of clinical activity and minimal toxicity. The underlying hypothesis of this research is that immunization against tumor neoantigens is effectively required to elicit antigen-reactive T cells capable of recognizing and eliminating cancer. Moreover, both quantitative and qualitative improvements in CD8 immunity are necessary (but not sufficient) for clinical response and improved survival. The goal of this study is to build on our prior clinical trial results in melanoma by studying the immune response to tumor neoantigens in patients with stage 1 NSCLC.

Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC)

-Blood for immunological response is drawn every week from Dose #1 to 6 weeks after Dose #3 (Day 1 to Day 126 = Week 18 and then every 4 weeks until Day 365)

Safety will be closely monitored after vaccination. Patients will be observed for 2 hours after the first dose and vital signs recorded every 30 minutes during that time period beginning at the start of the infusion. For each dose thereafter, patients will be observed in the treatment area for 30 minutes after the infusion. The following parameters will be assessed:

* Local signs and symptoms
* Systemic signs and symptoms
* Laboratory evaluations
* Adverse and serious adverse events
* Toxicity will be graded according to the NCI's CTCAE version 4.0.

These patients have been completed resected so there is no tumor response to monitor. CT scans evaluating for progression will be performed at baseline, following the third vaccine dose, and as per routine care during follow-up (generally every 3 months for the first year and every 6 months for the next 4 years thereafter).

Washington University School of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC)	NCT02419170	Carcinoma, Non-... Non-Small Cell ... Nonsmall Cell L...	Standard of car... Apheresis Cyclophosphamid... Personalized ma...	18 Years -	Washington University School of Medicine
Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC)	NCT02419170	Carcinoma, Non-... Non-Small Cell ... Nonsmall Cell L...	Standard of car... Apheresis Cyclophosphamid... Personalized ma...	18 Years -	Washington University School of Medicine

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