Clinical trial NCT03870529: High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer
Official title: A Pilot Study of Neoadjuvant High Dose Vitamin A for Resectable Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Non Small Cell Lung Cancer
Stage I Lung Cancer
Stage Ib Lung Carcinoma
Stage IA Lung Carcinoma AJCC V7
Stage IIA Lung Carcinoma
Stage IIIA Lung Carcinoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-03-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Presence or Absence of Germinal Centers in Resected Tissue
timeFrame: Up to 2 years
Secondary outcomes:
measure: Proportion of Germinal Centers in Lymph Nodes
timeFrame: Up to 2 years
measure: Presence or Absence of Tumor Necrosis
timeFrame: Up to 2 years
measure: Overall Survival
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: William J Petty, MD
role: PRINCIPAL_INVESTIGATOR
References: