Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery
Condition: Advanced Malignant Neoplasm; Metastatic Malignant Neoplasm; Unresectable Malignant Neoplasm
MeSH terms: Neoplasms
Intervention: Laboratory Biomarker Analysis; Muscadine Grape Skin Extract; Quality-of-Life Assessment
Intervention description: Correlative studies; Given PO; Ancillary studies
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase I trial studies the side effects and the best dose of muscadine grape skin extract
      (MGE) in treating patients with malignancy (tumor or cancer) that has spread to other parts
      of the body or cannot be removed by surgery. MGE is a nutritional supplement containing an
      extract of the skin of muscadine grape that has shown anti-cancer activity in laboratory
      studies and may be able to fight or kill malignant cells.
    

Eligibility criteria:

        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