Clinical trial · Interventional
Mature Dendritic Cell Vaccination Against Unique Immunogenic Peptides in Patients With Non Small Cell Lung Cancer (NSCLC)
NCT02419170CI-TRIAL-00023113withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator who manufactured the vaccine left the university.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell-Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Nonsmall Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apheresis | Procedure | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Personalized mature dendritic cell vaccine | Biological | — | UNRESOLVED |
| Standard of care surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surgery/Apheresis/Cyclophosphamide/Vaccine
- 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)
- interventionNames
- Procedure: Standard of care surgery
- Procedure: Apheresis
- Drug: Cyclophosphamide
- Biological: Personalized mature dendritic cell vaccine
Primary outcomes (2)
- measure
- Immunological response as measured by increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay
- timeFrame
- 1 year
- description
- -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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.