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

Completed · Phase 1

Conditions studied: Solid Cancers

In brief

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.

Key facts

Study ID

NCT01820299

Run by

Medical University of South Carolina

People needed

22

Starts

2013-03-01

Expected to finish

2016-05-01

Last updated by the study team

2018-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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