TerminatedEarly Phase 1NCT03870529
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedVitamin A Compound and Therapeutic Conventional Surgery

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 9, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Early Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Wake Forest University Health Sciences

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Early Phase 1
Sponsor
Wake Forest University Health Sciences
Interventions being studied
Drug: Vitamin A Compound; Procedure: Therapeutic Conventional Surgery
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 9, 2024. Always confirm current availability with the study team.

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