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

NCT ID: NCT02419170

Last Updated: 2016-07-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2023-10-31

Brief Summary

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.

Detailed Description

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.

Conditions

Carcinoma, Non-Small-Cell-Lung; Non-Small Cell Lung Cancer; Nonsmall Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery/Apheresis/Cyclophosphamide/Vaccine

• 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)

Group Type: EXPERIMENTAL

Standard of care surgery

Intervention Type: PROCEDURE

Apheresis

Intervention Type: PROCEDURE

Cyclophosphamide

Intervention Type: DRUG

Personalized mature dendritic cell vaccine

Intervention Type: BIOLOGICAL

Interventions

Standard of care surgery

Intervention Type: PROCEDURE

Apheresis

Intervention Type: PROCEDURE

Cyclophosphamide

Intervention Type: DRUG

Personalized mature dendritic cell vaccine

Intervention Type: BIOLOGICAL

Other Intervention Names

Cytoxan®

Eligibility Criteria

Inclusion Criteria

• Patients with completely resected stage I non-small cell lung cancer who are not considered for adjuvant post operative therapy.
• Age ≥ 18 years.
• ECOG performance status 0-1.
• HLA-A2 positive.
• Required initial laboratory values (submitted within 14 days prior to registration):

• WBC > 3,000/mm3
• Hg ≥ 9.0 gm/dL
• Platelets >75,000/mm3
• Serum bilirubin < 2.0 mg/dL
• Serum creatinine < 2.0 mg/dL
• Sexually active women of childbearing potential must use effective birth control during the trial and for at least two months following the trial, and sexually active men must be willing to avoid fathering a new child while receiving therapy.
• Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria

• Prior treatment with cytotoxic chemotherapy
• Prior treatment with targeted therapy or immunotherapy.
• Active untreated CNS metastasis.
• Active infection.
• Prior malignancy (except non-melanoma skin cancer) within 3 years.
• Pregnant or nursing.
• Concurrent treatment with systemic corticosteroids; local (inhaled or topical) steroids are permitted.
• Known allergy to eggs.
• Prior history or uveitis or autoimmune inflammatory eye disease.
• Known positivity for hepatitis B sAg, hepatitis C antibody, or HIV antibody.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramaswamy Govindan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

15-x043

Identifier Type: -

Identifier Source: org_study_id