Non Small Cell Lung Cancer, Stage IA Lung Carcinoma AJCC V7, Stage Ib Lung Carcinoma, Stage IIA Lung Carcinoma, Stage IIIA Lung Carcinoma, Stage I Lung Cancer
Conditions
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.
Interventions
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
PROCEDURETherapeutic Conventional Surgery
Participants randomized to this arm will receive surgical resection
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 11 |
| Therapeutic Conventional Surgery Description Participants undergo surgical resection.
Therapeutic Conventional Surgery: Participants randomized to this arm will receive surgical resection | 9 |
| Total | 20 |
Baseline characteristics
| Characteristic | Vitamin A Compound | Therapeutic Conventional Surgery | Total |
|---|---|---|---|
| Age, Continuous | 66.0 years STANDARD_DEVIATION 9 | 69.1 years STANDARD_DEVIATION 10.8 | 67.4 years STANDARD_DEVIATION 9.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 9 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 8 Participants | 19 Participants |
| Region of Enrollment United States | 11 participants | 9 participants | 20 participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 9 |
| other Total, other adverse events | 0 / 11 | 0 / 9 |
| serious Total, serious adverse events | 0 / 11 | 0 / 9 |
Outcome results
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.
Time frame: Up to 2 years
Population: No samples were analyzed for outcomes and the study was stopped therefore data was not collected for outcome measures
Secondary
Overall Survival
Overall survival of patients receiving neoadjuvant Vitamin A and in controls.
Time frame: Up to 2 years
Population: No samples were analyzed for outcomes and the study was stopped therefore data was not collected for outcome measures
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
Time frame: Up to 2 years
Population: No samples were analyzed for outcomes and the study was stopped therefore data was not collected for outcome measures
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.
Time frame: Up to 2 years
Population: No samples were analyzed for outcomes and the study was stopped therefore data was not collected for outcome measures