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

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Pilot Study of Neoadjuvant High Dose Vitamin A for Resectable Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03870529
• Other study ID #: IRB00050640
• Secondary ID: NCI-2018-00888WF
• Status: Terminated
• Phase: Early Phase 1
• Start date: August 19, 2019
• Est. completion date: December 9, 2022

Study information

• Verified date: December 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 9, 2022
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer
• Stage I Lung Cancer
• Stage IA Lung Carcinoma AJCC V7
• Stage Ib Lung Carcinoma
• Stage IIA Lung Carcinoma
• Stage IIIA Lung Carcinoma

Intervention

Drug:
• Vitamin A Compound
Participants randomized to this arm will receive 7 consecutive days of of Vitamin A compound without disease progression or unacceptable toxicities. Within 21 days of completion of treatment participants will undergo surgical resection

Procedure:
• Therapeutic Conventional Surgery
Participants randomized to this arm will receive surgical resection

Locations

Country	Name	City	State
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or Absence of Germinal Centers in Resected Tissue	Presence/absence of germinal centers (GCs) in resected cancer tissues from patients who receive neoadjuvant vitamin A and controls.	Up to 2 years
Secondary	Proportion of Germinal Centers in Lymph Nodes	Measurement of GCs per unit area in adjacent lymph nodes will be assessed using semi-quantitative designation (Score of high, moderate, low, or absent) in patients who receive neoadjuvant vitamin A and controls.	Up to 2 years
Secondary	Presence or Absence of Tumor Necrosis	Pathologic response will be defined by tumor necrosis which will be dichotomized as present or absent in patients who receive neoadjuvant vitamin A and controls	Up to 2 years
Secondary	Overall Survival	Overall survival of patients receiving neoadjuvant Vitamin A and in controls.	Up to 2 years