Solid Cancers
Conditions
Brief summary
This study is for subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes). The overall goal of this study is to identify plant-derived phytochemicals that can safely reduce systemic inflammation (inflammation throughout the entire body) in subjects with advanced cancer.
Detailed description
This study will look at oligomeric procyanidin complex (OPC) and vitamin D3. OPC is the major part of Grape Seed Extract (GSE). Researchers are in looking at the combination of GSE and vitamin D in subjects with solid cancers (gastrointestinal, lung, breast, prostate, lymphoma or cancer of the lymph nodes). Researchers will examine the safety of the GSE and vitamin D when GSE is given at different doses. Researchers will also look at the effects of GSE and vitamin D on your quality of life and your body. In particular, they will look at differences in biomarkers in your blood and urine.
Interventions
All patients enrolled to the study will take Grape Seed Extract alone for 21 days.
DRUGVitamin D
From Day 22 until Day 64 of the study, patients will take Grape Seed Extract and Vitamin D together. Patients will take Vitamin D once at a day at 4000 IU.
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have a histological diagnosis of cancer * Subjects must be 21 or more years of age * Subjects must have metastatic or locally advanced, unresectable cancer. Cancer must be active (i.e. demonstrable by physical examination, blood tests, or radiographical procedures). * Subjects may not initiate a new form of cancer therapy, non-steroidal or steroid anti-inflammatory agents, or antibiotics during the study period or for 4 weeks prior to the start of study agents. * Subjects must be able to give written consent to the study. * Subjects must have adequate hematologic, renal, and hepatic function at baseline, as follows: * Hematology parameters: ANC \>1500/mcL, platelets \> 100,000/mcL, Hgb \>8.0gm/dL * Renal Function: Creatinine \<1.8mg/mL * Liver Function: Total bilirubin ≤ULN, AST and ALT \<1.5xULN, Alk phosphatase \<2.5xULN * Subjects must have normal serum phosphate and serum calcium levels: * Serum Phosphate \> 2.3 and \< 4.8 mg/dL * Serum Calcium \> 8.5 and \< 10.5 * Subjects may be receiving anti-cancer treatment, but this treatment should be have been instituted at least 4 weeks prior to enrollment, and may not change during the study period.
Exclusion criteria
* Uncontrolled cancer requiring the institution of new anti-cancer therapy during the study period. * Presence of any severe or uncontrolled concurrent medical condition which, in the opinion of the investigator, would increase the risk of serious toxicity from the study drugs. * Any uncontrolled systemic inflammatory disease or infection requiring antibiotics, non-steroidal, or steroidal anti-inflammatory agents. * Initiation of strong antioxidant supplements during treatment, or ongoing use of supplements containing concentrated plant-derived polyphenols (pine bark, grape seed, green tea, milk thistle extracts; resveratrol; ellagic acid) * Pregnancy or breast feeding * Any history of allergies to grapes or grape seed. * Current treatment with lenalidomide, thalidomide, imipquimod, interferon, cytokines (G-CSF, GM-CSF, IL-1Rα), TNFα antagonists, or Lithium. * History of sarcoidosis * History of hypercalcemia * Use of any non-protocol vitamin D supplementation. * Uncontrolled hypertension * Current treatment with warfarin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximally-tolerated dose of Grape Seed Extract in Patients with Solid Tumors | 2 years | Decisions to escalate or expand a dose level will be based only on the GSE-only treatment period (day 1-21). To be evaluable for toxicity, a patient must receive at least 3 weeks of GSE treatment, or have experienced dose-limiting toxicity (DLT). All patients enrolled are to be fully followed for toxicity, but any patients who are not evaluable for toxicity will be replaced. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IL6 Response | 2 years | Plasma IL-6 levels before and after 21 days and 63 days of GSE treatment will be quantified to estimate the dose response relationship between GSE dose and reduction in inflammation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Other Inflammatory Markers | 2 years | Other markers that will be measured will include serum CRP, albumin, AGEs (advanced glycation end products), rAGE (soluble receptor for AGEs), 25-OH-vitamin D3, and urine for oxidative damage DNA biomarkers (urinary 8-oxoGua and 8-oxodG). Correlations between dose and change in these parameters from before to 21, 63 days after start of GSE dosing will be described. |
| Quality of Life Questionnaires | 2 years | Serial QOL assessments will be made by the FACT series of QOL questionnaires |
| Effect of Vitamin D3 on Anti-Inflammatory Effects of GSE | 2 years | The ability of a fixed dose of vitamin D3 (4000 IU daily) to further suppress IL-6 levels in subjects on GSE treatment will be evaluated. |
Countries
United States
Outcome results
None listed