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

Early Phase 1

Terminated

• Conditions: Stage IA Lung Carcinoma AJCC V7; Stage IIIA Lung Carcinoma; Stage I Lung Cancer; Stage IIA Lung Carcinoma; Stage Ib Lung Carcinoma; Non Small Cell Lung Cancer
• Interventions: Drug: Vitamin A Compound; Procedure: Therapeutic Conventional Surgery

• Registration Number: NCT03870529
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Study Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-12
• Study Start: 2019-08-19
• Primary Completion: 2022-12-09
• Study Completion: 2022-12-09
• Results First Submitted: 2023-11-20
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Results First Posted: 2024-01-09
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient must be 18 years of age or older.
• Patients must have either biopsy proven or radiographically suspected non-small cell lung cancer.
• Patients must have disease in the chest that is felt to be surgically resectable.
• ECOG performance status of 0-2.
• Ability to understand and the willingness to sign an IRB-approved informed consent document

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Exclusion Criteria

• Patients younger than 18 years of age
• Women who are pregnant or breast feeding.
• Patients may not be receiving any other investigational agents for the treatment of nonsmall cell lung cancer.
• Patients may not be taking the following medications: high dose vitamin A supplement (multivitamin supplements prohibited only if vitamin A content is greater than 3,500 international units), bexarotene, alitretinoin, tretinoin, adapalene, isotretinoin, acitretin, doxycycline, minocycline, or demeclocycline,
• Uncontrolled intercurrent illness including, but not limited to, pancreatitis, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Hypervitaminosis A - toxic effects of ingesting too much vitamin A.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin A compound	Vitamin A Compound	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.
Therapeutic Conventional Surgery	Therapeutic Conventional Surgery	Description Participants undergo surgical resection.

Primary Outcome Measures

Name	Time	Method
Presence or Absence of Germinal Centers in Resected Tissue	Up to 2 years	Presence/absence of germinal centers (GCs) in resected cancer tissues from patients who receive neoadjuvant vitamin A and controls.

Secondary Outcome Measures

Name	Time	Method
Presence or Absence of Tumor Necrosis	Up to 2 years	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	Up to 2 years	Overall survival of patients receiving neoadjuvant Vitamin A and in controls.
Proportion of Germinal Centers in Lymph Nodes	Up to 2 years	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.

Trial Locations

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States