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

NCT ID: NCT03870529

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-19
• Study Completion Date: 2022-12-09

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin A compound

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.

Group Type: EXPERIMENTAL

Vitamin A Compound

Intervention Type: DRUG

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

Therapeutic Conventional Surgery

Description Participants undergo surgical resection.

Group Type: ACTIVE_COMPARATOR

Therapeutic Conventional Surgery

Intervention Type: PROCEDURE

Participants randomized to this arm will receive surgical resection

Interventions

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

Intervention Type: DRUG

Therapeutic Conventional Surgery

Participants randomized to this arm will receive surgical resection

Intervention Type: PROCEDURE

Other Intervention Names

Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraen-1-ol, 68-26-8, A 313, Anti-Infective Vitamin, Anti-Infective vitamin, Antixerophthalmic Vitamin, Antixerophthalmic vitamin

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William J Petty, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2018-00888

Identifier Type: OTHER

Identifier Source: secondary_id

WFBCCC 62218

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00050640

Identifier Type: -

Identifier Source: org_study_id