Phase I Study: safety and immunogenicity of vaccination with XAGE1B long peptides combined with poly-ICLC in patients with pulmonary adenocarcinoma

Completed

Conditions: lung carcinoma
non small cell lung cancer
10038666
10029107

Registration Number: NL-OMON45223

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

For stage I&II pulmonary adenocarcinoma patients:
* Histologically proven pulmonary adenocarcinoma stage I or II according to recent guidelines on TNM classification of NSCLC
* Age * 18 years
* Completion of curative resection or SBRT and adjuvant chemotherapy or radiotherapy if necessary according to guidelines.
* Good WHO performance status (0-2)
* Adequate bone marrow function: WBC * 2.0 x 109/l, platelets > 100 x 109/l, hemoglobin > 5.0 mmol/L
* Survival expectation > 3 months
* Written informed consent according to the local Ethics Committee requirements;For stage III pulmonary adenocarcinoma patients:;* Histologically proven pulmonary adenocarcinoma stage IIIb according to recent guidelines on TNM classification of NSCLC.
* Age * 18 years
* Completion of standard chemo-radiotherapy
* No intention for further chemotherapy treatment
* Good WHO performance status (0-2)
* Adequate bone marrow function: WBC * 2.0 x 109/l, platelets > 100 x 109/l, hemoglobin > 5.0 mmol/L
* Survival expectation > 3 months
* Written informed consent according to the local Ethics Committee requirements;For stage IV pulmonary adenocarcinoma patients:
* Histologically proven pulmonary adenocarcinoma stage IV according to recent guidelines on TNM classification of NSCLC 1.
* Age * 18 years
* Completion of standard (platinum-based) chemotherapy schedules with no intention for further chemotherapy treatment
* Good WHO performance status (0-2)
* Adequate bone marrow function: WBC * 2.0 x 109/l, platelets > 100 x 109/l, hemoglobin > 5.0 mmol/L
* Survival expectation > 3 months
* Written informed consent according to the local Ethics Committee requirements

Exclusion Criteria

* Progressive disease after finishing standard treatment
* Inadequate bone marrow function more than 3 weeks after last chemotherapy treatment.
* Poor WHO performance status (3-5)
* Eligibility for treatment with Tyrosine Kinase Inhibitors (e.g. erlotinib)
* History of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or patients receiving immunosuppressive therapy including transplant recipients
* Second primary tumor of non-pulmonary origin
* CD4 cell count < 200/m3 at baseline
* Known seropositivity for Hepatitis B Virus and/or HIV
* History of serious liver or kidney dysfunction, heart condition or thyroid disorder
* Pregnancy or Lactating
* Known hypersensitivity reaction to any of the components used during treatment
* Medical or psychological condition which in the opinion of the treating chest physician and investigator would not permit the patient to participate in or to complete the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety will be assessed during the whole study by collecting all adverse events<br /><br>according to the CTC version 3 and by monitoring vital signs, blood chemistry<br /><br>and hematological parameters.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Immunological assessments will be performed in all vaccinated patients using a<br /><br>blood sample drawn at several time points (day 1, 22 and 43) and a skin biopsy<br /><br>of the last vaccination site. Immunological responses will be monitored using<br /><br>peripheral blood lymphocytes that are tested by IFN-ELISPOT and intracellular<br /><br>IFN/IL-2 staining for directly ex-vivo detection and enumeration of<br /><br>antigen-specific CD4+ and/or CD8+ T-cells, as well as following one round of in<br /><br>vitro stimulation. In addition, proliferation (lymphocyte stimulation test:<br /><br>LST) and associated cytokine production (IFN, TNF, IL-4, IL-5, IL-10, and<br /><br>IL-2) will be assessed. Furthermore, biopsy samples of the last vaccination<br /><br>site will be used to assess the migratory capacity of vaccine-induced T-cells.</p><br>