Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer

ONCB-006-19F

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.

2023-09-18

2027-01-04

2027-04-01

Recruiting

Early phase I

30

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a phase IIa, single arm study using 2-3 weeks of oral LP treatment for stage I and II lung cancer patients before surgical resection of their tumors', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-09-22