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

Primary Purpose

Non Small Cell Lung Cancer, Stage I Lung Cancer, Stage Ib Lung Carcinoma

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin A Compound
Therapeutic Conventional Surgery
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Wake Forest Baptist Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitamin A compound

Therapeutic Conventional Surgery

Arm 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.

Description Participants undergo surgical resection.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Overall Survival
Overall survival of patients receiving neoadjuvant Vitamin A and in controls.

Full Information

First Posted
March 8, 2019
Last Updated
September 19, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03870529
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Slow accruals
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
December 9, 2022 (Actual)
Study Completion Date
December 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin A compound
Arm Type
Experimental
Arm 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.
Arm Title
Therapeutic Conventional Surgery
Arm Type
Active Comparator
Arm Description
Description Participants undergo surgical resection.
Intervention Type
Drug
Intervention Name(s)
Vitamin A Compound
Other Intervention Name(s)
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
Intervention Description
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
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Participants randomized to this arm will receive surgical resection
Primary Outcome Measure Information:
Title
Presence or absence of germinal centers in resected tissue
Description
Presence/absence of germinal centers (GCs) in resected cancer tissues from patients who receive neoadjuvant vitamin A and controls.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Proportion of Germinal Centers in Lymph Nodes
Description
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.
Time Frame
Up to 2 years
Title
Presence or Absence of Tumor Necrosis
Description
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
Time Frame
Up to 2 years
Title
Overall Survival
Description
Overall survival of patients receiving neoadjuvant Vitamin A and in controls.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William J Petty, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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