- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515004
Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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: Patients who have suspected early stage lung cancer will be recruited from Pulmonary and Thoracic Surgery clinics prior to diagnostic biopsy.
Following informed consent, which includes allowing the investigators to collect and store some of the samples from the clinical diagnostic procedures as pretreatment samples, such as bronchoscopy, needle aspirations, etc., subject will be screened with history and physical examination (H & P), respiratory/general health questionnaires, food frequency self-assessment questionnaires, review of medical records, including radiographic imaging data, pulmonary function test (PFT), 12-lead EKG, clinical labs (complete blood chemistry panel, blood cell counts, PT, PTT). Most of these diagnostic tests will have already been obtained as a part of the clinical work up. However, new blood tests will be obtained if the last results were over 3 months ago). Blood samples and urine samples will be collected for research. Serum cotinine will be obtained to ascertain smoking status. A portion of the biospecimens (blood, urine, diagnostic samples) collected will be kept for future research at the NMVAHCS in an approved repository. A pregnancy test will be done for a woman who is able to have children.
Intervention: (treatment with study medication). If stage I or II lung cancer is diagnosed from standard clinical practice, the qualified subject will be enrolled into the intervention study to receive 2-3 weeks of LP, taken by mouth once a day, until the lung cancer surgery. At the time of surgery, serial clinical samples, including bronchoscopic and various surgically resected tissues, blood and urine will be collected as post-treatment samples. Pre- and post-treatment samples will be compared to assess how well oral LP has been absorbed, and whether or not there are encouraging anti-cancer changes occurring in the cells and molecules in response to the LP treatment. Once enrolled for intervention, all subjects will be monitored with weekly phone follow up, the safety of LP will be monitored weekly using standard reporting tools (including the NCI common terminology criteria for adverse events Version 5.0 and adverse reaction questionnaires), as well as pre-surgery H&P and blood tests.
Follow up: Post-surgery phone follow up will occur at 3-4 weeks, 6 months and annually for up to 4 years.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jenny T Mao, MD
- Phone Number: (858) 642-6403
- Email: jenny.mao@va.gov
Study Locations
-
-
California
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San Diego, California, United States, 92161-0002
- Recruiting
- VA San Diego Healthcare System, San Diego, CA
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Contact:
- Jenny T Mao, MD
- Phone Number: 858-642-6403
- Email: jenny.mao@va.gov
-
Principal Investigator:
- Jenny T. Mao, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
All qualified participants meeting entry criteria that are enrolled will receive 2-3 weeks of oral LP treatment.
|
A standardized grape seed procyanidin extract complexed with soy phospholipid.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delay in the planned surgery of >14 days that is possibly related to study medication (Safety and feasibility).
Time Frame: No greater than 14 days delay in planned surgery.
|
Defined as no delay in the planned surgery of >14 days that is possibly related to study medication.
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No greater than 14 days delay in planned surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor Ki-67 labeling index (LI), a marker of cell proliferation.
Time Frame: 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
|
Modulations of tumor Ki-67 LI.
|
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.
Time Frame: 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
|
Tumors and lymph nodes with no more than 10% viable tumor cells will be considered to have had a major pathological response.
|
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.
Time Frame: 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
|
Modulations of this marker of apoptosis in tumors.
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor COX-2.
Time Frame: 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
|
Modulation of COX-2 expression in Tumor.
|
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.
Time Frame: 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
|
Modulations of this marker of inflammation and immunity in biospecimens.
|
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.
Time Frame: 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
|
Modulations of this marker of inflammation and immunity in biospecimens.
|
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
|
PGE2.
Time Frame: 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
|
Modulations of this marker of inflammation and immunity in biospecimens.
|
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
|
CRP.
Time Frame: 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
|
Modulations of this marker of inflammation and immunity in biospecimens.
|
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
|
MicroRNA (miR)-19a
Time Frame: 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
|
Modulations of this oncogenic miRNA in serum and tumors.
|
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 PTEN.
Time Frame: 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
|
Modulations of this marker of cancerization.
|
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
|
MicroRNA (miR)-19b
Time Frame: 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
|
Modulations of this oncogenic miRNA in serum and tumors.
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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 p-AKT
Time Frame: 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
|
Modulations of this marker of cancerization.
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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
|
MicroRNA (miR)-106b
Time Frame: 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
|
Modulations of this oncogenic miRNA in serum and tumors.
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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
|
Stage of lung cancer
Time Frame: 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
|
Change of lung cancer stage based on the American Joint Committee on Cancer (AJCC) TNM staging system.
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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
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PGI2.
Time Frame: 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
|
Modulations of this marker of inflammation and immunity in biospecimens.
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jenny T. Mao, MD, VA San Diego Healthcare System, San Diego, CA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONCB-006-19F
- I01CX002028 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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