Clinical trial NCT02419170: Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC)
Official title: Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Carcinoma, Non-Small-Cell-Lung
Non-Small Cell Lung Cancer
Nonsmall Cell Lung Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Immunological response as measured by increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay
timeFrame: 1 year
measure: Safety and tolerability of vaccine as measured by adverse events experienced and graded by NCI CTCAE Version 4.0
timeFrame: 30 days after last vaccine (approximately Day 115)
Secondary outcomes:
measure: Time to progression (TTP)
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Ramaswamy Govindan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: