Advanced Malignant NeoplasmPhase 1NCT02583269
Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery
A Phase 1 study testing Laboratory Biomarker Analysis, Muscadine Grape Skin Extract and Quality-of-Life Assessment in people with Advanced Malignant Neoplasm and Metastatic Malignant Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Unresectable Malignant Neoplasm
- What is being tested?
- Laboratory Biomarker Analysis, Muscadine Grape Skin Extract and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 24 Apr 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Phase I Study of Muscadine Grape Extract (MGE) in Advanced Malignancy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Unresectable Malignant Neoplasm
- Being tested
- Laboratory Biomarker Analysis, Muscadine Grape Skin Extract, Quality-of-Life Assessment
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisDiagnostic test
Correlative studies
Muscadine Grape Skin ExtractDrug
Also called MSKE
Given PO
Quality-of-Life AssessmentProcedure or surgery
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (muscadine grape skin extract) 1 pill 2 times a day | Experimental | Patients 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. Receives: Diagnostic Test: Laboratory Biomarker Analysis; Drug: Muscadine Grape Skin Extract; Procedure: Quality-of-Life Assessment |
| Arm 2 (muscadine grape skin extract) 2 pills 2 times a day | Experimental | Patients 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. Receives: Diagnostic Test: Laboratory Biomarker Analysis; Drug: Muscadine Grape Skin Extract; Procedure: Quality-of-Life Assessment |
| Arm 3 (muscadine grape skin extract) 3 pills 2 times a day | Experimental | Patients 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. Receives: Diagnostic Test: Laboratory Biomarker Analysis; Drug: Muscadine Grape Skin Extract; Procedure: Quality-of-Life Assessment |
| Arm 4 (muscadine grape skin extract) 4 pills 2 times a day | Experimental | Patients 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. Receives: Diagnostic Test: Laboratory Biomarker Analysis; Drug: Muscadine Grape Skin Extract; Procedure: Quality-of-Life Assessment |
| Arm 5 muscadine grape skin extract) 5 pills 2 times a day | Experimental | Patients 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. Receives: Diagnostic Test: Laboratory Biomarker Analysis; Drug: Muscadine Grape Skin Extract; Procedure: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 29 days
Secondary outcomes (15)
Adherence to MGE Treatment, as Measured by Percent of Pills Taken at the End of Every 4 Week Period
Pill count will be calculated from counting the number of pills returned as well as by summarizing the patient's pill diary. The percent of pills taken will be summarized by dose level using the median and 95% confidence interval. Investigators will summarize the percent of pills taken at the end of every 4 week period i using the formula: Percent of pills taken)i = (Dose Level ×7 ×4)i minus Pill Count divided by Dose Level ×7 ×4)i
Measured: Up to 1 year
Best Response
Best response will be characterized using a frequency table. Evaluation of new or enlarging effusions to differentiate between Progressive Disease and Response/Stable Disease. Measurements will be obtained from usual care imaging and assessed by the principal investigators in confirmation with the physician of record. Clinical lesions will only be considered measurable when they are superficial and ≥10 mm in diameter as assessed using calipers. For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion, is recommended.
Measured: At the end of treatment, up to 1 year
Change in Total Phenolic Levels in Blood
A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.
Measured: Baseline to up to 8 weeks
Change in Total Phenolic Levels in Urine
A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.
Measured: Baseline to up to 8 weeks
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G
A mixed model ANOVA model will be fit with phenolic level as the outcome and time (baseline, every 4 weeks) as a fixed effect and subject as a random effect. Contrasts will be use to estimate changes from baseline to each follow-up time period. Score scales from 0 (not at all) to 4 (very much). Sum of scores range 0-28 for social, functional and physical well being and 0-24 for emotional well being and multiplied by 6. All four scores are totaled with a score range of 0-108. A mean of the combined group scores will be used. A higher score indicates a higher worse outcome of the illness on the participant.
Measured: Baseline to up to 1 year
Change in Systemic Cytokine Levels
A mixed model ANOVA model will fit with the outcome of interest (cytokine or growth factor) as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.
Measured: Baseline to up to 8 weeks
Incidence of Adverse Events (AEs), Assessed Using NCI CTCAE Version 4.0
AEs/toxicity will be assessed at weeks 4, 8 and every 4 weeks thereafter if patients remain on treatment. Any expected toxicities, any laboratory based toxicities, and any grade 3 or higher gastrointestinal toxicities, and any grade 4 or higher toxicities will be summarized using frequency tables overall and by week.
Measured: Up to 1 year
Overall Response Rate of MGE (Complete Response, Partial Response, and Stable Disease)
Response will be characterized using a frequency table.
Measured: At 8 weeks
Overall Survival (OS)
OS will summarized using the Kaplan-Meier method. Median survival rates and associated 95% confidence intervals will be calculated.
Measured: Up to 4 years
Progression-free Survival (PFS)
PFS will summarized using the Kaplan-Meier method.
Measured: Up to 4 years
Change in Component Phenolic Levels in Urine
A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.
Measured: Baseline to up to 8 weeks
Change in Component Phenolic Levels in Blood
A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.
Measured: Baseline to up to 8 weeks
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by PROMIS-Fatigue SF
A mixed model ANOVA model will be fit with phenolic level as the outcome and time (baseline, every 4 weeks) as a fixed effect and subject as a random effect. Contrasts will be use to estimate changes from baseline to each follow-up time period. A 6-item questionnaire with T-score responses ranging from a minimum of 33.4 to a maximum of 76.8. Higher scores equals more of the concept being measured.
Measured: Baseline to up to 1 year
Change in Systemic Cytokine Levels (Log IL-8)
A mixed model ANOVA model will fit with the outcome of interest (cytokine or growth factor) as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.
Measured: Baseline to up to 8 weeks
Change in Systemic Cytokine Levels (Log VEGF)
A mixed model ANOVA model will fit with the outcome of interest (cytokine or growth factor) as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.
Measured: Baseline to up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startMar 2016
- Primary completion19 Dec 2017
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heidi Klepin, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583269
- Sponsor's protocol ID
- IRB00035394
- Other IDs
- NCI-2015-01710, CCCWFU 01815, P30CA012197
- Status last verified
- May 2023
- First submitted
- 13 Oct 2015
- Last updated
- 5 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 33867481
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Muscadine Grape Extract (MGE) in Advanced Malignancy
- ClinicalTrials.gov ID
- NCT02583269
- Acronym / sponsor ID
- IRB00035394
- Conditions
- Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Unresectable Malignant Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2016 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Posted 12 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (muscadine grape skin extract) 1 pill 2 times a day | Experimental | Diagnostic Test: Laboratory Biomarker Analysis, Drug: Muscadine Grape Skin Extract, Procedure: Quality-of-Life AssessmentPatients 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 | Experimental | Diagnostic Test: Laboratory Biomarker Analysis, Drug: Muscadine Grape Skin Extract, Procedure: Quality-of-Life AssessmentPatients 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 | Experimental | Diagnostic Test: Laboratory Biomarker Analysis, Drug: Muscadine Grape Skin Extract, Procedure: Quality-of-Life AssessmentPatients 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 | Experimental | Diagnostic Test: Laboratory Biomarker Analysis, Drug: Muscadine Grape Skin Extract, Procedure: Quality-of-Life AssessmentPatients 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 | Experimental | Diagnostic Test: Laboratory Biomarker Analysis, Drug: Muscadine Grape Skin Extract, Procedure: Quality-of-Life AssessmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Diagnostic test | Arm 1 (muscadine grape skin extract) 1 pill 2 times a day, Arm 2 (muscadine grape skin extract) 2 pills 2 times a day, Arm 3 (muscadine grape skin extract) 3 pills 2 times a day, Arm 4 (muscadine grape skin extract) 4 pills 2 times a day, Arm 5 muscadine grape skin extract) 5 pills 2 times a day |
| Muscadine Grape Skin ExtractAlso: MSKEGiven PO | Drug | Arm 1 (muscadine grape skin extract) 1 pill 2 times a day, Arm 2 (muscadine grape skin extract) 2 pills 2 times a day, Arm 3 (muscadine grape skin extract) 3 pills 2 times a day, Arm 4 (muscadine grape skin extract) 4 pills 2 times a day, Arm 5 muscadine grape skin extract) 5 pills 2 times a day |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Procedure or surgery | Arm 1 (muscadine grape skin extract) 1 pill 2 times a day, Arm 2 (muscadine grape skin extract) 2 pills 2 times a day, Arm 3 (muscadine grape skin extract) 3 pills 2 times a day, Arm 4 (muscadine grape skin extract) 4 pills 2 times a day, Arm 5 muscadine grape skin extract) 5 pills 2 times a day |
Primary outcome
Number of Participants With Dose-Limiting Toxicity
Time frame: 29 days
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.
15 secondary outcomes
Adherence to MGE Treatment, as Measured by Percent of Pills Taken at the End of Every 4 Week Period
Time frame: Up to 1 year
Best Response
Time frame: At the end of treatment, up to 1 year
Change in Total Phenolic Levels in Blood
Time frame: Baseline to up to 8 weeks
Change in Total Phenolic Levels in Urine
Time frame: Baseline to up to 8 weeks
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G
Time frame: Baseline to up to 1 year
Change in Systemic Cytokine Levels
Time frame: Baseline to up to 8 weeks
Incidence of Adverse Events (AEs), Assessed Using NCI CTCAE Version 4.0
Time frame: Up to 1 year
Overall Response Rate of MGE (Complete Response, Partial Response, and Stable Disease)
Time frame: At 8 weeks
Overall Survival (OS)
Time frame: Up to 4 years
Progression-free Survival (PFS)
Time frame: Up to 4 years
Change in Component Phenolic Levels in Urine
Time frame: Baseline to up to 8 weeks
Change in Component Phenolic Levels in Blood
Time frame: Baseline to up to 8 weeks
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by PROMIS-Fatigue SF
Time frame: Baseline to up to 1 year
Change in Systemic Cytokine Levels (Log IL-8)
Time frame: Baseline to up to 8 weeks
Change in Systemic Cytokine Levels (Log VEGF)
Time frame: Baseline to up to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33867481Bitting 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Klepin principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Laboratory Biomarker Analysis, Muscadine Grape Skin Extract and Quality-of-Life Assessment in people with Advanced Malignant Neoplasm and Metastatic Malignant Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-Limiting Toxicity (time frame: 29 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02583269, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.