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

• Status: Withdrawn
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Cyclophosphamide; Vaccines

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.