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

NCT03870529 | Terminated Early Phase 1 Results FDA Drug

• 4 other identifiers: IRB00050640NCI-2018-00888WFBCCC 62218P30CA012197
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 2 years

Secondary Outcomes (3)

• Proportion of Germinal Centers in Lymph Nodes

  Up to 2 years

• Presence or Absence of Tumor Necrosis

  Up to 2 years

• Overall Survival

  Up to 2 years

Study Arms (2)

Vitamin A compound

EXPERIMENTAL

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

Therapeutic Conventional Surgery

ACTIVE COMPARATOR

Description Participants undergo surgical resection.

Procedure: Therapeutic Conventional Surgery

Interventions

Vitamin A Compound DRUG

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

Also known as: 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

Vitamin A compound

Therapeutic Conventional Surgery PROCEDURE

Participants randomized to this arm will receive surgical resection

Therapeutic Conventional Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Study Coordinator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

jkettler@wakehealth.edu

336-716-4760

Study Officials

• William J Petty, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 12, 2019
• Study Start: August 19, 2019
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)