High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03870529|
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : July 24, 2020
|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|
I. To compare the percentage of resected cancers containing germinal centers (GCs) in patients who receive neoadjuvant vitamin A compound (vitamin A) to controls.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Neoadjuvant High Dose Vitamin A for Resectable Non-Small Cell Lung Cancer|
|Actual Study Start Date :||August 19, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
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 Name: 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
- Presence or absence of germinal centers in resected tissue [ Time Frame: Up to 2 years ]Presence/absence of germinal centers (GCs) in resected cancer tissues from patients who receive neoadjuvant vitamin A and controls.
- Proportion of Germinal Centers in Lymph Nodes [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 2 years ]Overall survival of patients receiving neoadjuvant Vitamin A and in controls.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870529
|Contact: Sharon Averill, RNfirstname.lastname@example.org@wakehealth.edu|
|United States, North Carolina|
|Wake Forest Baptist Comprehensive Cancer Center||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||William J Petty, MD||Wake Forest University Health Sciences|