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Trial record 3 of 131 for:    Recruiting, Not yet recruiting, Available Studies | "Vitamin A"

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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 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 : August 19, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

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 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Overall Survival [ Time Frame: Up to 2 years ]
    Overall survival of patients receiving neoadjuvant Vitamin A and in controls.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Sharon Averill, RN 336-716-0230 saverill@wakehealth.edu@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: William J Petty, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03870529    
Other Study ID Numbers: WFBCCC 62218
NCI-2018-00888 ( Other Identifier: Clinical Trial Reporting Program )
IRB00050640 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin A
Retinol palmitate
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vitamins
Anti-Infective Agents
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents