Status:
TERMINATED
Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer
Lead Sponsor:
VA Office of Research and Development
Conditions:
Early Stage Lung Cancer (I and II)
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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 hig...
Detailed Description
The investigators will conduct a phase IIa, single arm study using 2-3 weeks of oral LP treatment for 30 early stage I and II lung cancer patients before surgical resection of their tumors. Screening...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04515004
Start Date
November 20 2023
End Date
March 31 2025
Last Update
June 17 2025
Active Locations (1)
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1
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002