Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Anti-Infective Agents

All Drugs and Chemicals

Micronutrients

Antineoplastic Agents

Vitamins

Vitamin A

Retinol palmitate

Trace Elements

Antioxidants

Protective Agents

Retinol

Participants receive vitamin A compound 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.

Description Participants undergo surgical resection.

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

Vitamin A Compound

Participants randomized to this arm will receive surgical resection

Therapeutic Conventional Surgery

William J Petty, MD

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.

High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer

A Pilot Study of Neoadjuvant High Dose Vitamin A for Resectable Non-Small Cell Lung Cancer

Presence/absence of germinal centers (GCs) in resected cancer tissues from patients who receive neoadjuvant vitamin A and controls.

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.

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

Overall survival of patients receiving neoadjuvant Vitamin A and in controls.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Participants receive vitamin A compound 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.

Vitamin A Compound: 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

Description Participants undergo surgical resection.

Therapeutic Conventional Surgery: Participants randomized to this arm will receive surgical resection

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study Coordinator

No samples were analyzed for outcomes and the study was stopped therefore data was not collected for outcome measures

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer	NCT03870529	Non Small Cell ... Stage I Lung Ca... Stage Ib Lung C... Stage IA Lung C... Stage IIA Lung ... Stage IIIA Lung...	Vitamin A Compo... Therapeutic Con...	18 Years -	Wake Forest University Health Sciences
High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer	NCT03870529	Non Small Cell ... Stage I Lung Ca... Stage Ib Lung C... Stage IA Lung C... Stage IIA Lung ... Stage IIIA Lung...	Vitamin A Compo... Therapeutic Con...	18 Years -	Wake Forest University Health Sciences

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