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A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
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| Phase II | Biomarker/Laboratory analysis, Treatment | Active | 18 and over | SCCI 07-001.1
NCT00631852 |
Trial Description
Summary This study was designed to explore the changes brought about by gelatin encapsulated extract of American Ginseng Root (LEAG) in breast cancer tumors and surrounding normal breast epithelial cells. Various tumor biomarkers, as well as inflammatory mediators, will be examined in tissue following LEAG treatment. Eligibility Criteria Inclusion Criteria: - Patients with cytologically confirmed breast cancer with biopsy showing invasive or non-invasive (DCIS) at least 0.5 cm on imaging
- Surgical patients undergoing lumpectomy, subtotal or total mastectomy
- 18 years of age or greater
- available tissue blocks from diagnostic biopsy
- negative pregnancy test, medical history of surgical sterilization, or 1 year post menopausal
- must be willing to forego surgery for minimum of 5 days
- ability and willingness to sign written consent
- if hypertensive, on stable dose of medication at least 30 days
- if diabetic, well controlled (HbA1C 7.5-8.5 within past 60 days or documented FPG < 140 mg/dl for 3 consecutive days
- ECOG status < 2 or Karnofsky of 60% or greater
Exclusion Criteria: - patients with previous or current malignancy, excluding non-melanomic skin cancer
- evidence of distant metastatic disease
- patients who have had chemotherapy, biologic or radiotherapy with 6 months of biopsy
- usage of herbal supplements or alternative medications not approved by the FDA within 1 week of starting study drug. LEAG or related ginseng products, and combination products containing ginseng, should be discontinued within 6 weeks of starting study drug
- history of allergic reactions attributed to compounds of similar chemical or biologic composition to LEAG
- history of chronic inflammatory process, including, but not limited to, rheumatoid arthritis and lupus. This includes patients on concurrent systemic steroids or anti-inflammatory medications
- active bleeding or a pathological condition that carries a high risk of bleeding
- patients with any swallowing dysfunction
- Uncontrolled intercurrent illness
Trial Contact Information
Trial Lead Organizations/Sponsors Simmons Cooper Cancer Institute | Elizabeth Peralta, M.D. | | Principal Investigator |
Trial Sites
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| U.S.A. |
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| Illinois |
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Springfield |
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| | | | | | | | | Simmons Cooper Cancer Institute |
| | | Elizabeth Peralta, M.D. |
Ph: 217-545-7230 |
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Email:
eperalta@siumed.edu |
| | | Susan Klug, RN, BSN, ONC |
Ph: 217-545-7929 |
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Email:
sklug@siumed.edu |
| | | Elizabeth A. Peralta | Principal Investigator |
| | | Gary L. Dunnington | Sub-Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00631852
Information obtained from ClinicalTrials.gov on March 18, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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