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Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients With Advanced Cancer

Phase 1
18 Years
Open (Enrolling)
Solid Cancers

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Trial Information

Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients With Advanced Cancer

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.

Inclusion Criteria:

- Subjects must have a histological diagnosis of cancer with an elevated baseline
plasma IL-6 level (>3.0 pg/mL) as determined by Dr. Lilly's laboratory.

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximally-tolerated dose of Grape Seed Extract in Patients with Solid Tumors

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Michael Lilly, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina


United States: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

March 2014

Related Keywords:

  • Solid Cancers



Medical University of South CarolinaCharleston, South Carolina  29425-0721