Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer

NCT04515004 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: ONCB-006-19FI01CX002028
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early Stage Lung Cancer (I and II)

Keywords

Grape seed procyanidin extract; Early stage lung cancer; Neoadjuvant treatment

Outcome Measures

Primary Outcomes (1)

• Delay in the Planned Surgery of >14 Days That is Possibly Related to Study Medication (Safety and Feasibility).

  Defined as no delay in the planned surgery of \>14 days that is possibly related to study medication.

  No greater than 14 days delay in planned surgery.

Secondary Outcomes (3)

• Tumor Ki-67 Labeling Index (LI), a Marker of Cell Proliferation.

  Interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2

• Histopathology: Pathological Response of Resected Tumor and Lymph Nodes.

  Interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2

• Tumor Activated Caspase 3.

  Interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2

Other Outcomes (12)

• Tumor COX-2.

  Interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2

• 15-HETE.

  Interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2

• IL-6.

  Interim analysis on matched, pre- and post-treatment comparisons will be performed after 10 subjects have completed the treatment portion of the study, anticipated to be in year 2

Study Arms (1)

Intervention

EXPERIMENTAL

All qualified participants meeting entry criteria that are enrolled will receive 2-3 weeks of oral LP treatment.

Drug: leucoselect phytosome

Interventions

leucoselect phytosome DRUG

A standardized grape seed procyanidin extract complexed with soy phospholipid.

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Interventions

leucoselect phytosome

Limitations and Caveats

Due to early study termination, the effects of the intervention cannot be determined.

Results Point of Contact

• Title: Jenny T. Mao, M.D.
• Organization: VA San Diego

jenny.mao@va.gov

8585528585

Study Officials

• Jenny T. Mao, MD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 17, 2020
• Study Start: November 20, 2023
• Primary Completion: November 1, 2024
• Study Completion: March 31, 2025
• Last Updated: February 17, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)