High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer (NCT03870529) | Clinical Trial Compass
TerminatedEarly Phase 1
High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer
Stopped: Slow accruals
United States20 participantsStarted 2019-08-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
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.
What they're measuring
1
Presence or Absence of Germinal Centers in Resected Tissue