Clinical trial NCT01820299: Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients With Advanced Cancer
Official title: Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Cancers
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximally-tolerated dose of Grape Seed Extract in Patients with Solid Tumors
timeFrame: 2 years
Secondary outcomes:
measure: IL6 Response
timeFrame: 2 years
Other outcomes:
measure: Measurement of Other Inflammatory Markers
timeFrame: 2 years
measure: Quality of Life Questionnaires
timeFrame: 2 years
measure: Effect of Vitamin D3 on Anti-Inflammatory Effects of GSE
timeFrame: 2 years
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Michael Lilly, MD
role: PRINCIPAL_INVESTIGATOR
References: