A Vaccine (CIMAvax-EGF) for the Prevention of Lung Cancer Development or Recurrence

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PRIMARY OBJECTIVES: I. To determine the efficacy of the vaccine based on circulating EGF and anti-EGF antibodies. II. To access the molecular profile of blood, bronchial and nasal brushes, and bronchial biopsies to identify molecular markers associated with treatment and response. III. To establish ...

PRIMARY OBJECTIVES: I. To determine the efficacy of the vaccine based on circulating EGF and anti-EGF antibodies. II. To access the molecular profile of blood, bronchial and nasal brushes, and bronchial biopsies to identify molecular markers associated with treatment and response. III. To establish the safety of recombinant human EGF-rP64K/montanide ISA 51 vaccine (CIMAvax-EGF) treatment in cancer-free individuals using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 5). SECONDARY OBJECTIVE: I. To evaluate quality of life score changes using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30) in patients who are at high risk for development of lung cancer or recurrence during CIMAvax-EGF treatment. OUTLINE: LOADING PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine intramuscularly (IM) at 0, 2, 4 and 6 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine IM once every 4 weeks (Q4W) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 60 days.

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