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A Pilot Study of Neoadjuvant High Dose Vitamin A for Resectable Non-Small Cell Lung Cancer
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Start Date
August 19, 2019
Primary Completion Date
December 9, 2022
Completion Date
December 9, 2022
Last Updated
January 9, 2024
20
ACTUAL participants
Vitamin A Compound
DRUG
Therapeutic Conventional Surgery
PROCEDURE
Lead Sponsor
Wake Forest University Health Sciences
Collaborators
NCT07485114
NCT06066138
Data Source & Attribution
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