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

NCT01820299 | Completed Phase 1 DMC

• 1 other identifier: 101839
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Cancers

Outcome Measures

Primary Outcomes (1)

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

  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.

  2 years

Secondary Outcomes (1)

• IL6 Response

  2 years

Other Outcomes (3)

• Measurement of Other Inflammatory Markers

  2 years

• Quality of Life Questionnaires

  2 years

• Effect of Vitamin D3 on Anti-Inflammatory Effects of GSE

  2 years

Study Arms (1)

Grape Seed Extract and Vitamin D

EXPERIMENTAL

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.

Drug: Grape Seed Extract; Drug: Vitamin D

Interventions

Grape Seed Extract DRUG

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

Also known as: GSE

Grape Seed Extract and Vitamin D

Vitamin D 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.

Grape Seed Extract and Vitamin D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29412, United States

Location

MeSH Terms

Interventions

Grape Seed Extract; Vitamin D

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Michael Lilly, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: March 28, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 18, 2018

Record last verified: 2018-05

Locations

US (1)