Malignant MelanomaEarly Phase 1NCT04285749
Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas
A Early Phase 1 study testing Fluvastatin, RNA-sequencing and Gene expression profiling in people with Malignant Melanoma, run by Case Comprehensive Cancer Center.
Trial summary
The purpose of this study is to determine whether a medication, fluvastatin, can change melanoma to a state that is less likely to metastasize or recur. Fluvastatin is experimental in this setting because it is not approved by the Food and Drug Administration (FDA) for treatment or prevention of melanoma. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Fluvastatin, RNA-sequencing and Gene expression profiling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2020to 1 Apr 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed melanoma clinically staged as AJCC Stage 1-3.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participant having received a statin drug within 1 month of study enrollment.
- Participant receiving any other investigational agents.
- History of adverse reactions (eg. myalgias, transaminitis, or rhabdomyolysis) attributed to compounds of similar chemical or biologic composition to fluvastatin or other agents used in this study.
- Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver disease, or psychiatric illness/social situations that would limit compliance with study requirements.
- Participant currently pregnant (as assessed by positive pregnancy test prior to enrollment) or breastfeeding
- --Pregnant or breastfeeding women are excluded from this study because Fluvastatin has the potential for teratogenic or abortifacient effects. Women of childbearing potential will be asked to take a pregnancy test prior to enrollment (unless a pregnancy test administered within the last month is present in the medical record and is negative). A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant. Men do not need to use contraception while taking this medication.
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- Participants currently receiving BRAF inhibitors, MEK inhibitors, immunotherapy, or any other non-surgical treatment for melanoma.
- Participants currently receiving nucleoside reverse transcriptase inhibitors. These participants are excluded because use of NRTIs may confound the transcriptome measurements used in this study since as described above they are predicted to modify melanoma gene expression.
- Any condition or situation that, in the investigator's opinion, may put the patient at significant risk, or may significantly interfere with the patient's participation in the study.
- Participants concurrently taking macrolide antibiotics (eg erythromycin, clarithromycin), azole antifungals (eg itraconazole, ketoconazole), protease inhibitors (eg ritonavir, telaprevir), gemfibrozil, cyclosporine, danazol, amiodarone, amlodipine, verapamil, diltiazem, azithromycin, carbamazepine, phenytoin, or rifampin are excluded.
- Participants with baseline ALT greater than 3 times the upper limit of normal.
About this study
The purpose of this study is to determine whether a medication, fluvastatin, can change melanoma to a state that is less likely to metastasize or recur.
Fluvastatin is experimental in this setting because it is not approved by the Food and Drug Administration (FDA) for treatment or prevention of melanoma. However, fluvastatin has been approved by the FDA for treating high cholesterol.
Read the detailed description
This is an open-label, single arm, study assessing the activity of fluvastatin in shifting the transcriptome in melanoma. Subjects with melanoma will be asked to participate and all subjects will receive the study drug, fluvastatin, for 2 weeks.
The primary objective of this study to determine whether administration of fluvastatin changes the melanoma transcriptome
The secondary objective of this study is to determine whether administration of fluvastatin changes the gene expression profile of Class 2 melanoma to Class 1 melanoma.
- Conditions
- Malignant Melanoma
- Being tested
- Fluvastatin, RNA-sequencing, Gene expression profiling
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluvastatinDrug
Fluvastatin PO 80mg QD for 2 weeks
RNA-sequencingOther
RNA-sequencing will be completed on the original diagnostic biopsy and the final melanoma excision
Gene expression profilingOther
Gene expression profiling will be completed on the original diagnostic biopsy and the final melanoma excision
| Study group | Role | What they receive |
|---|---|---|
| Fluvastatin | Experimental | Participants will receive Fluvastatin for 2 weeks.
RNA-sequencing and gene expression profiling will be completed on the original diagnostic biopsy and the final melanoma excision. Receives: Drug: Fluvastatin; Other: RNA-sequencing; Other: Gene expression profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic profile shift in melanoma transcriptome
The study team will report which of the 28 genes had significant expression changes. A 2-fold change in the appropriate direction with a p-value of at least 0.05 will be considered significant for potential therapeutic value. P-values will be corrected for the false discovery rate using the Benjamini-Hochberg procedure. Fluvastatin successful in shifting the genetic profile in a therapeutic manner if at least half of the 28 genes have significant expression changes
Measured: Two weeks
Secondary outcomes (1)
Number of patients who convert from Class 2 to Class 1
Number of patients who convert from Class 2 to Class 1 profile on retesting
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start6 Nov 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Why it stopped: PI moving to new institution prior to study activation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wesley Yu, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285749
- Sponsor's protocol ID
- CASE4619
- Status last verified
- Jul 2020
- First submitted
- 24 Feb 2020
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This study is a pilot study to help assess the power needed for a larger study and to determine biologic activity. If a larger study is conducted, data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Recurrence and Metastasis in Genetically High-Risk Melanomas
- ClinicalTrials.gov ID
- NCT04285749
- Acronym / sponsor ID
- CASE4619
- Conditions
- Malignant Melanoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI moving to new institution prior to study activation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 6 Nov 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a medication, fluvastatin, can change melanoma to a state that is less likely to metastasize or recur.
Fluvastatin is experimental in this setting because it is not approved by the Food and Drug Administration (FDA) for treatment or prevention of melanoma. However, fluvastatin has been approved by the FDA for treating high cholesterol.
Detailed description
This is an open-label, single arm, study assessing the activity of fluvastatin in shifting the transcriptome in melanoma. Subjects with melanoma will be asked to participate and all subjects will receive the study drug, fluvastatin, for 2 weeks.
The primary objective of this study to determine whether administration of fluvastatin changes the melanoma transcriptome
The secondary objective of this study is to determine whether administration of fluvastatin changes the gene expression profile of Class 2 melanoma to Class 1 melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluvastatin | Experimental | Drug: Fluvastatin, Other: RNA-sequencing, Other: Gene expression profilingParticipants will receive Fluvastatin for 2 weeks. RNA-sequencing and gene expression profiling will be completed on the original diagnostic biopsy and the final melanoma excision. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically or cytologically confirmed melanoma clinically staged as AJCC Stage 1-3.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (11 listed)
- Participant having received a statin drug within 1 month of study enrollment.
- Participant receiving any other investigational agents.
- History of adverse reactions (eg. myalgias, transaminitis, or rhabdomyolysis) attributed to compounds of similar chemical or biologic composition to fluvastatin or other agents used in this study.
- Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver disease, or psychiatric illness/social situations that would limit compliance with study requirements.
- Participant currently pregnant (as assessed by positive pregnancy test prior to enrollment) or breastfeeding
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 |
|---|---|---|
| FluvastatinFluvastatin PO 80mg QD for 2 weeks | Drug | Fluvastatin |
| RNA-sequencingRNA-sequencing will be completed on the original diagnostic biopsy and the final melanoma excision | Other | Fluvastatin |
| Gene expression profilingGene expression profiling will be completed on the original diagnostic biopsy and the final melanoma excision | Other | Fluvastatin |
Primary outcome
Genetic profile shift in melanoma transcriptome
Time frame: Two weeks
The study team will report which of the 28 genes had significant expression changes. A 2-fold change in the appropriate direction with a p-value of at least 0.05 will be considered significant for potential therapeutic value. P-values will be corrected for the false discovery rate using the Benjamini-Hochberg procedure. Fluvastatin successful in shifting the genetic profile in a therapeutic manner if at least half of the 28 genes have significant expression changes
1 secondary outcome
Number of patients who convert from Class 2 to Class 1
Time frame: Two weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: No. This study is a pilot study to help assess the power needed for a larger study and to determine biologic activity. If a larger study is conducted, data will be shared.
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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.
Wesley Yu, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fluvastatin, RNA-sequencing and Gene expression profiling in people with Malignant Melanoma, run by Case Comprehensive Cancer Center.
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 2 inclusion and 11 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: withdrawn, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Genetic profile shift in melanoma transcriptome (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2020.