Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer (NCT04515004) | Clinical Trial Compass
TerminatedPhase 2
Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer
Stopped: Early termination by sponsor due to substantial delays with subjects recruitment
United States6 participantsStarted 2023-11-20
Plain-language summary
Lung cancer is the leading cause of cancer death in the country, surpassing deaths caused by colorectal, prostate and breast cancers combined. Veterans are at higher risk of lung cancer due to the higher rate of smoking and environmental toxin exposures. The lack of effective therapy for lung cancer provides the impetus to search for alternative, safe, and effective treatment agents to improve treatment strategy against lung cancer, enhance the probability of a cure and reduce recurrence. Based on encouraging preclinical and clinical findings from an early phase I lung cancer prevention study, using a special formulation of a standardized grape seed extract with enhanced absorption called leucoselect phytosome (LP), the purpose of this new CSR\&D Merit Review project is to evaluate the potential usefulness of LP for pre-surgical treatment of early stage lung cancer patients in a phase IIa clinical trial. Findings from this study may set the stage for larger, confirmatory trials in the near future.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
A. Initial screening:
* Lesions suspicious for lung cancer
* Competent to provide consent
* CBC within normal limits (WNL)
* liver function test WNL
* Normal Creatinine clearance as measured by the Cockcroft-Gault equation
* ECOG Performance status: 0-1
B. Enrollment for treatment with LP:
* Histologically proven and surgically resectable clinical I and II stage NSCLC
Exclusion Criteria:
* Inability to provide informed consent (e.g. cognitive impairment, severe psychiatric disorders)
* Hypersensitivity to grapes or related products
* Advance respiratory disease (Post resection FEV1 \< 0.8 liters, resting hypoxemia, to ensure pts have adequate reserve to undergo diagnostic procedures and surgical resection)
* Unstable angina
* Other concurrent malignancy, excluding non-melanoma type skin cancer
* Have had a solid organ or bone marrow transplant
* Pregnancy
* Breast feeding
* Systemic corticoid steroid therapy of \> 10 mg prednisone equivalent daily
* Coagulopathy (PT-INR \> 1.2, PTT \> 40 seconds) or history of bleeding/clotting problems
* Concurrent use of Grapes or related products
* Unwilling to refrain from drinking more than 1 glass of wine a day
* Pts receiving medications known to be modulators of cytochrome P450 3A4 if alternative medication cannot be provided
* Currently taking other investigational agents
* Pts with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Delay in the Planned Surgery of >14 Days That is Possibly Related to Study Medication (Safety and Feasibility).
Timeframe: No greater than 14 days delay in planned surgery.