Status:
TERMINATED
High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Non Small Cell Lung Cancer
Stage I Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 ge...
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 OBJEC...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03870529
Start Date
August 19 2019
End Date
December 9 2022
Last Update
January 9 2024
Active Locations (1)
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1
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157