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

The Washington University

Status and phase: Withdrawn; Early Phase 1

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

Treatments: Procedure: Apheresis; Procedure: Standard of care surgery; Drug: Cyclophosphamide; Biological: Personalized mature dendritic cell vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02419170

15-x043

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Surgery/Apheresis/Cyclophosphamide/Vaccine

Experimental group

Description:

* 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)

Treatment:

Procedure: Apheresis

Drug: Cyclophosphamide

Procedure: Standard of care surgery

Biological: Personalized mature dendritic cell vaccine