Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery
Phase I Study of Muscadine Grape Extract (MGE) in Advanced Malignancy
4 other identifiers
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2017
CompletedResults Posted
Study results publicly available
September 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2023
CompletedJune 5, 2023
May 1, 2023
1.8 years
October 13, 2015
May 7, 2019
June 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Dose-Limiting Toxicity
Maximum tolerable dose of muscadine grape extract is defined as the dose level immediately below the dose level that induced a dose-limiting toxicity (DLT) in \>= 2 patients, as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0DLT will be assessed by severity of adverse events.
29 days
Secondary Outcomes (15)
Adherence to MGE Treatment, as Measured by Percent of Pills Taken at the End of Every 4 Week Period
Up to 1 year
Best Response
At the end of treatment, up to 1 year
Change in Total Phenolic Levels in Blood
Baseline to up to 8 weeks
Change in Total Phenolic Levels in Urine
Baseline to up to 8 weeks
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G
Baseline to up to 1 year
- +10 more secondary outcomes
Study Arms (5)
Arm 1 (muscadine grape skin extract) 1 pill 2 times a day
EXPERIMENTALPatients receive muscadine grape skin extract PO 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.
Arm 2 (muscadine grape skin extract) 2 pills 2 times a day
EXPERIMENTALPatients receive muscadine grape skin extract PO 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.
Arm 3 (muscadine grape skin extract) 3 pills 2 times a day
EXPERIMENTALPatients receive muscadine grape skin extract PO 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.
Arm 4 (muscadine grape skin extract) 4 pills 2 times a day
EXPERIMENTALPatients receive muscadine grape skin extract PO 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.
Arm 5 muscadine grape skin extract) 5 pills 2 times a day
EXPERIMENTALPatients receive muscadine grape skin extract PO 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.
Interventions
Correlative studies
Given PO
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Related Publications (1)
Bitting RL, Tooze JA, Isom S, Petty WJ, Grant SC, Desnoyers RJ, Thomas A, Thomas CY, Alistar AT, Golden SL, Pleasant K, Chappell MC, Tallant EA, Gallagher PE, Klepin HD. Phase I Study of Muscadine Grape Extract for Patients With Advanced Cancer. Am J Clin Oncol. 2021 Jun 1;44(6):239-246. doi: 10.1097/COC.0000000000000814.
PMID: 33867481DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Nurse
- Organization
- Wake Forest University Health Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Heidi Klepin
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2015
First Posted
October 22, 2015
Study Start
March 1, 2016
Primary Completion
December 19, 2017
Study Completion
April 24, 2023
Last Updated
June 5, 2023
Results First Posted
September 12, 2019
Record last verified: 2023-05