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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03870529

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

39.4

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: Vitamin A Compound Procedure: Therapeutic Conventional Surgery	Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:

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:

To compare the abundance of GCs in adjacent lymph nodes in patients who receive neoadjuvant vitamin A to controls.
To compare histopathologic responses based on tumor necrosis in lung cancer patients who receive neoadjuvant vitamin A to controls.
To compare overall survival of patients who receive neoadjuvant vitamin A to controls.

EXPLORATORY OBJECTIVES:

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 19, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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 Other 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
Active Comparator: Therapeutic Conventional Surgery Description Participants undergo surgical resection.	Procedure: Therapeutic Conventional Surgery Participants randomized to this arm will receive surgical resection

Arm

Intervention/Treatment

Experimental: 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.

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

Other 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

Active Comparator: Therapeutic Conventional Surgery

Description Participants undergo surgical resection.

Procedure: Therapeutic Conventional Surgery

Participants randomized to this arm will receive surgical resection

Outcome Measures

Primary Outcome Measures

Presence or absence of germinal centers in resected tissue [Up to 2 years]
Presence/absence of germinal centers (GCs) in resected cancer tissues from patients who receive neoadjuvant vitamin A and controls.

Secondary Outcome Measures

Proportion of Germinal Centers in Lymph Nodes [Up to 2 years]
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.
Presence or Absence of Tumor Necrosis [Up to 2 years]
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
Overall Survival [Up to 2 years]
Overall survival of patients receiving neoadjuvant Vitamin A and in controls.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.