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

Wake Forest University (WFU)

Status and phase: Terminated; Early Phase 1

Conditions: Stage Ib Lung Carcinoma; Stage IIA Lung Carcinoma; Stage IIIA Lung Carcinoma; Stage IA Lung Carcinoma AJCC V7; Non Small Cell Lung Cancer; Stage I Lung Cancer

Treatments: Drug: Vitamin A Compound; Procedure: Therapeutic Conventional Surgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03870529

IRB00050640 (Other Identifier)

P30CA012197 (U.S. NIH Grant/Contract)

WFBCCC 62218

NCI-2018-00888 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Vitamin A compound

Experimental group

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.

Treatment:

Drug: Vitamin A Compound

Therapeutic Conventional Surgery

Active Comparator group

Description:

Description Participants undergo surgical resection.

Treatment:

Procedure: Therapeutic Conventional Surgery