NL-OMON45223
Completed
Not Applicable
Phase I Study: safety and immunogenicity of vaccination with XAGE1B long peptides combined with poly-ICLC in patients with pulmonary adenocarcinoma - XAGE trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- lung carcinoma
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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