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

NCT ID: NCT01820299

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-05-31

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.

Conditions

Solid Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Grape Seed Extract and Vitamin D

All patients will take Grape Seed Extract from Day 1 to Day 21. All patients will take Grape Seed Extract and Vitamin D together from Day 22 until Day 64. For all patients on the study, patients will take Vitamin D once a day at a dose of 4000IU.

Group Type: EXPERIMENTAL

Grape Seed Extract

Intervention Type: DRUG

All patients enrolled to the study will take Grape Seed Extract alone for 21 days.

Vitamin D

Intervention Type: DRUG

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.

Interventions

Grape Seed Extract

All patients enrolled to the study will take Grape Seed Extract alone for 21 days.

Intervention Type: DRUG

Vitamin 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.

Intervention Type: DRUG

Other Intervention Names

GSE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Michael Lilly

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Lilly, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

101839

Identifier Type: -

Identifier Source: org_study_id