Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery

PRIMARY OBJECTIVES:

I. To determine the safety and maximum tolerated dose (MTD) of MGE (muscadine grape skin
extract) after 4 weeks of administration for patients with metastatic cancer.

Secondary Objectives:

I. To monitor adverse events/toxicity every 4 weeks while on treatment. II. To evaluate
change in phenolic levels (total and component, blood and urine) from baseline to 4 and 8
weeks.

III. To evaluate change in serum cytokines and growth factors from baseline to 4 and 8 weeks
on MGE.

IV. To observe the response rate of MGE in patients with metastatic cancer. V. To assess
overall and progression-free survival in patients with metastatic cancer receiving MGE.

VI. To assess global quality of life (Functional Assessment of Cancer Therapy-General
[FACT-G] and fatigue (Patient Reported Outcomes Measurement Information System
[PROMIS]-fatigue Short Form [SF]) in cancer patients taking MGE.

VII. To assess adherence to MGE treatment.

OUTLINE: This is a dose-escalation study.

Patients receive muscadine grape skin extract orally (PO) twice daily (BID). Treatment
continues for 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients experiencing benefit from muscadine grape skin extract may continue treatment in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and then every 6
weeks.

Inclusion Criteria:

- Patients must have histologically confirmed malignancy that is metastatic or
unresectable and have failed standard therapies

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation; should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately

- Ability to understand and the willingness to sign an Institutional Review Board
(IRB)-approved informed consent document

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Absolute neutrophil count >= 1000/mcL

- Platelets >= 50,000/mcL

- Total bilirubin within normal institutional limits

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT]/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2.5 X institutional upper limit or normal

- Creatinine clearance >= 40 mL/min

- Stable supplement usage for > 2 weeks prior to starting and agrees not to change while
on this study

- Life expectancy > 3 months

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

- Patients may not be receiving any other investigational cancer-directed agents

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to MGE

- Patients unable to take oral medications or those with history of malabsorption due to
bowel resection

- Patients with uncontrolled diarrhea or persistent nausea/vomiting requiring daily
antiemetic therapy for symptom management

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study; breastfeeding should be discontinued

- Patients with primary brain tumors are excluded