Phase 1
N=24
Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery
Advanced Malignant Neoplasm · Metastatic Malignant Neoplasm · Unresectable Malignant Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT02583269 ↗Enrolled (actual)
24
Serious AEs
9.5%
Results posted
Sep 2019
Primary outcome: Primary: Number of Participants With Dose-Limiting Toxicity — 0; 1; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Laboratory Biomarker Analysis (Diagnostic_test); Muscadine Grape Skin Extract (Drug); Quality-of-Life Assessment (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-Limiting Toxicity |
0; 1; 0; 0; 0 | — |
| SECONDARY Adherence to MGE Treatment, as Measured by Percent of Pills Taken at the End of Every 4 Week Period |
97.8 | — |
| SECONDARY Best Response |
8; 8 | — |
| SECONDARY Change in Total Phenolic Levels in Blood |
2123.8; 2049.3; 2308.1 | — |
| SECONDARY Change in Total Phenolic Levels in Urine |
1107.2; 1024.5; 1274.6 | — |
| SECONDARY Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G |
80.6; 79.4; 81.1; 17.7; 17.7; 16.5 | 0.76 |
| SECONDARY Change in Systemic Cytokine Levels |
NA; NA; NA; 4.74; 4.95; 4.97 | — |
| SECONDARY Incidence of Adverse Events (AEs), Assessed Using NCI CTCAE Version 4.0 |
3; 3; 2; 2; 5 | — |
| SECONDARY Overall Response Rate of MGE (Complete Response, Partial Response, and Stable Disease) |
8; 8 | — |
| SECONDARY Overall Survival (OS) |
7.2 | — |
| SECONDARY Progression-free Survival (PFS) |
3.0 | — |
| SECONDARY Change in Component Phenolic Levels in Urine |
0.4; 19.7; 16.6 | — |
| SECONDARY Change in Component Phenolic Levels in Blood |
— | — |
| SECONDARY Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by PROMIS-Fatigue SF |
56.2; 57.3; 55.3 | 0.67 |
| SECONDARY Change in Systemic Cytokine Levels (Log IL-8) |
1.49; 1.32; 1.40 | 0.119 |
| SECONDARY Change in Systemic Cytokine Levels (Log VEGF) |
2.78; 2.81; 2.84 | 0.851 |
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 = = 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]) = = 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
Data sourced from ClinicalTrials.gov (NCT02583269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.