NCT03870529

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

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non Small Cell Lung Cancer
• Stage I Lung Cancer
• Stage Ib Lung Carcinoma
• Stage IA Lung Carcinoma AJCC V7
• Stage IIA Lung Carcinoma
• Stage IIIA Lung Carcinoma

Interventions

Type	Name	Description
DRUG	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
PROCEDURE	Therapeutic Conventional Surgery	Participants randomized to this arm will receive surgical resection

Timeline

• Start date: 2019-08-19
• Primary completion: 2022-12-09
• Completion: 2022-12-09
• First posted: 2019-03-12
• Last updated: 2024-01-09
• Results posted: 2024-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study