Non Small Cell Lung CancerEarly Phase 1NCT03870529
High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer
A Early Phase 1 study testing Vitamin A Compound and Therapeutic Conventional Surgery in people with Non Small Cell Lung Cancer and Stage I Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Stage I Lung Cancer, Stage Ib Lung Carcinoma
- What is being tested?
- Vitamin A Compound and Therapeutic Conventional Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2019to 9 Dec 2022
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study of Neoadjuvant High Dose Vitamin A for Resectable Non-Small Cell Lung Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
- 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
- Being tested
- Vitamin A Compound, Therapeutic Conventional Surgery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A CompoundDrug
Also called 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
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
Therapeutic Conventional SurgeryProcedure or surgery
Participants randomized to this arm will receive surgical resection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vitamin A Compound |
| Therapeutic Conventional Surgery | Active comparator | Description Participants undergo surgical resection. Receives: Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (3)
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.
Measured: Up to 2 years
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
Measured: Up to 2 years
Overall Survival
Overall survival of patients receiving neoadjuvant Vitamin A and in controls.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start19 Aug 2019
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Why it stopped: Slow accruals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William J Petty, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870529
- Sponsor's protocol ID
- IRB00050640
- Other IDs
- NCI-2018-00888, WFBCCC 62218, P30CA012197
- Status last verified
- Dec 2023
- First submitted
- 8 Mar 2019
- Last updated
- 9 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Neoadjuvant High Dose Vitamin A for Resectable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03870529
- Acronym / sponsor ID
- IRB00050640
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accruals
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Posted 9 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin A compound | Experimental | Drug: Vitamin A CompoundParticipants 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. |
| Therapeutic Conventional Surgery | Active comparator | Procedure: Therapeutic Conventional SurgeryDescription Participants undergo surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin A CompoundAlso: 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 vitaminParticipants 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 | Drug | Vitamin A compound |
| Therapeutic Conventional SurgeryParticipants randomized to this arm will receive surgical resection | Procedure or surgery | Therapeutic Conventional Surgery |
Primary outcome
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.
3 secondary outcomes
Proportion of Germinal Centers in Lymph Nodes
Time frame: Up to 2 years
Presence or Absence of Tumor Necrosis
Time frame: Up to 2 years
Overall Survival
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William J Petty, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vitamin A Compound and Therapeutic Conventional Surgery in people with Non Small Cell Lung Cancer and Stage I Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or Absence of Germinal Centers in Resected Tissue (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.