Clinical trial · Interventional
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
NCT03870529CI-TRIAL-00072825terminatedEarly Phase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accruals
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Stage IA Lung Carcinoma AJCC V7 | Lung Carcinoma | CURATED_BROADER | 0.78 |
| Stage Ib Lung Carcinoma | Lung Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIA Lung Carcinoma | Lung Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIA Lung Carcinoma | Lung Carcinoma | CURATED_BROADER | 0.78 |
| Stage I Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
| Vitamin A Compound | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vitamin A compound
- description
- 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.
- interventionNames
- Drug: Vitamin A Compound
- type
- ACTIVE_COMPARATOR
- label
- Therapeutic Conventional Surgery
- description
- Description Participants undergo surgical resection.
- interventionNames
- Procedure: Therapeutic Conventional Surgery
Primary outcomes (1)
- measure
- Presence or Absence of Germinal Centers in Resected Tissue
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.