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Phase I Clinical Trial Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Malignant Colon Tissue

Phase 1
20 Years
Open (Enrolling)
Colon Cancer

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Trial Information

Phase I Clinical Trial Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Malignant Colon Tissue

Curcumin is a constituent of the spice turmeric, which is one of the primary ingredients of
curry powder. Curcumin has been shown to interfere with colon carcinogenesis in a variety
of chemical and genetic rodent models. It has also been shown to have a strong inhibitory
effect on the growth of colon cancer cell lines. There is considerable evidence that the
effects of curcumin are mediated by changes in signal transduction. There is an extensive
body of work showing effects on several signaling pathways, including the beta-catenin and
NF-κB pathways. Although curcumin has been viewed as an ideal chemopreventative agent in
colon cancer for many years, its application has been impeded by important issues with drug
delivery and bioavailability in the reported clinical trials of this compound.

Work from the James Graham Brown Cancer Center published recently suggests that using
exosomes as a delivery vehicle leads to overcoming all the major obstacles of using curcumin
as an anti-inflammatory agent, including increased stability, solubility, and
bioavailability of curcumin. The work was further extended to define the resource that can
supply a large quantity of exosomes with a maximum binding capacity of curcumin. Emerging
data indicate that exosomes derived from many fruits release exosome-like particles,
strongly bind to many hydrophobic drugs including curcumin, and are taken up by the
intestine cells as well as the immune cells in the intestine. These results suggest that
these fruit-derived exosomes are potentially used as a delivery vehicle to treatment of
intestinal diseases. Moreover, both fruit exosomes and curcumin should not generate any
side-effects since they are consumed by humans daily.

In this clinical trial, the effect of exosomally delivered curcumin on the immune
modulation, cellular metabolism, and phospholipid profile of normal and malignant colon
cells in subjects who are undergoing surgery for newly diagnosed colon cancer will be
characterized. In selected subjects, the effect of exosomally delivered curcumin on the
production of cytokines, the changes of immune cells, and glucose metabolism by
administration of 13C-glucose prior to surgical resection will also be characterized.

Inclusion Criteria:

- Subjects must have definitive diagnosis of colon cancer.

- Surgical resection of the primary tumor must be an option for the newly diagnosed

- No history of diabetes

- Subjects must be informed of the investigational nature of this study and sign and
give written informed consent in accordance with institutional and federal

- Absence of life-limiting medical conditions

- Ability to understand and willingness to sign a written informed consent document.

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Karnofsky >
60%; see Appendix A).

- Subjects must have adequate bone marrow function. ANC > 1000/microliters (microL) and
Platelet count >100,000/microL

- Age >20 years

Exclusion Criteria:

- Known familial colon cancer syndrome

- Pregnancy

- Known Human Immunodeficiency Virus (HIV)

- Patients receiving immunosuppressive drugs

- Inflammatory bowel disease

- Active second malignancy in the last 5 years

- Patients receiving any other investigational agent(s)

- Patients who have received any prior chemotherapy or radiation therapy to the primary
colon cancer

- Intolerance to grapes, grapefruit, or curcumin

- History of diabetes mellitus

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Concentration of curcumin in normal and cancerous tissue

Outcome Description:

Concentration of curcumin delivered with curcumin alone or curcumin conjugated with plant exosomes to normal and cancerous colon cells will be compared. This exploratory trial is designed to estimate the effect of a fixed concentration of curcumin when delivered by plant exosomes compared to oral tablets of curcumin alone.

Outcome Time Frame:

7 days after start of curcumin ingestion

Safety Issue:


Principal Investigator

Donald M Miller, MD, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center


United States: Institutional Review Board

Study ID:

BCC-GI-10 Curcumin



Start Date:

January 2011

Completion Date:

January 2014

Related Keywords:

  • Colon Cancer
  • curcumin
  • plant exosomes
  • malignant colon tissue
  • Colonic Neoplasms



James Graham Brown Cancer Center Louisville, Kentucky  40202