This trial studies how well high dose vitamin A compound works in treating participants with non-small cell lung cancer that can be removed by surgery. Vitamin A compound may increase the number of germinal centers (immune centers that make antibodies mature) in tumor and lymph tissues which may be beneficial to patients with cancer.
PRIMARY OBJECTIVES: I. To compare the percentage of resected cancers containing germinal centers (GCs) in patients who receive neoadjuvant vitamin A compound (vitamin A) to controls. SECONDARY OBJECTIVES: I. To compare the abundance of GCs in adjacent lymph nodes in patients who receive neoadjuvant vitamin A to controls. II. To compare histopathologic responses based on tumor necrosis in lung cancer patients who receive neoadjuvant vitamin A to controls. III. To compare overall survival of patients who receive neoadjuvant vitamin A to controls. EXPLORATORY OBJECTIVES: I. To describe immunophenotypic changes of monocytes including myeloid derived suppressor cells (MDSCs) in pre- and post-treatment blood samples. OUTLINE: Participants are randomized to 1 of 2 groups. GROUP I: Participants receive vitamin A compound orally (PO) for 7 consecutive days in the absence of disease progression or unacceptable toxicity. Within 21 days of completing treatment, participants then undergo surgical resection. GROUP II: Participants undergo surgical resection. After completion of study treatment, participants are followed up for 30 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Participants randomized to this arm will receive 7 consecutive days of of Vitamin A compound without disease progression or unacceptable toxicities. Within 21 days of completion of treatment participants will undergo surgical resection
Participants randomized to this arm will receive surgical resection
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Presence or Absence of Germinal Centers in Resected Tissue
Presence/absence of germinal centers (GCs) in resected cancer tissues from patients who receive neoadjuvant vitamin A and controls.
Time frame: Up to 2 years
Proportion of Germinal Centers in Lymph Nodes
Measurement of GCs per unit area in adjacent lymph nodes will be assessed using semi-quantitative designation (Score of high, moderate, low, or absent) in patients who receive neoadjuvant vitamin A and controls.
Time frame: Up to 2 years
Presence or Absence of Tumor Necrosis
Pathologic response will be defined by tumor necrosis which will be dichotomized as present or absent in patients who receive neoadjuvant vitamin A and controls
Time frame: Up to 2 years
Overall Survival
Overall survival of patients receiving neoadjuvant Vitamin A and in controls.
Time frame: Up to 2 years
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