Recurrent MelanomaNCT02236546

FDG-PET in Advanced Melanoma

A study testing [18F]fluorodeoxyglucose, Molecular assays on biopsied tissue and positron emission tomography in people with Recurrent Melanoma and Stage IIIA Melanoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This clinical trial studies how well FDG-PET/CT measures early response in patients with stage III-IV melanoma who are receiving chemotherapy. Positron emission tomography (PET)/computed tomography (CT) uses a metabolic imaging radiotracer, [18F]fluorodeoxyglucose (FDG), which selectively accumulates in tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma
What is being tested?: [18F]fluorodeoxyglucose, Molecular assays on biopsied tissue and positron emission tomography
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: May 2012to Nov 2015
Phase: Interventional
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

Subjects must have signed Institutional Review Board (IRB)-approved informed consent documentation
Subjects must be diagnosed with histologically proven stage IV (metastatic) melanoma or stage III with bulky disease which may or may not be amenable for surgery and are receiving therapy at present
Subjects must be scheduled to begin treatment through the Vanderbilt-Ingram Cancer Center (VICC) Melanoma Program; this will include patients receiving standard-of-care chemotherapy, targeted therapy, and/or immunotherapy, as well as patients accrued to VICC clinical trials for the study of investigational agents
Subjects must have measurable disease by CT or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; to comply with PET Response Criteria in Solid Tumors (PERCIST) criteria, subjects should have at least one lesion measuring at least 2 cm in the longest diameter

Who cannot join

Subjects who are pregnant or nursing; urine pregnancy test/or serum human chorionic gonadotropin (HCG) will be performed on women of child bearing potential
Subjects who have experienced allergic or other adverse reactions in response to intravenous injection of fluorinated radiotracers and other contrast media used in PET/CT
Subjects incapable of giving informed written consent, for the following reasons:
Inability to adhere to the experimental protocols for any reason
Inability to communicate with the research team
Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders
Prisoners or other individuals deemed to be susceptible to coercion

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: FDG-PET/CT as a Biomarker for Treatment Response in Advanced Melanoma

Read the detailed description

PRIMARY OBJECTIVES:

To correlate treatment-induced changes in FDG uptake with changes in tumor size and progression-free survival (PFS) in patients receiving therapy for advanced melanoma.

II. To correlate treatment-induced changes in FDG uptake with changes in the activity and/or expression of available molecular biomarkers from patients receiving therapy for advanced melanoma.

OUTLINE:

Patients undergo FDG-PET/CT up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84).

Conditions: Recurrent Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma
Being tested: [18F]fluorodeoxyglucose, Molecular assays on biopsied tissue, positron emission tomography, computed tomography
Keywords: fluorodeoxyglucose, FDG, PET/CT, melanoma, imaging biomarkers, cancer imaging
Medical subject headings: Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[18F]fluorodeoxyglucoseDiagnostic test
Also called 18-F-deoxy-glucose, 18-F-deoxyglucose, FDG, fluorodeoxyglucose F-18
FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
Molecular assays on biopsied tissueOther
Also called immunohistochemistry, genetic assay, laboratory biomarker analysis, molecular profiling
Correlative studies
positron emission tomographyDevice
Also called PET, PET scan, tomography, emission computed
Undergo FDG-PET/CT
computed tomographyDevice
Also called CT, tomography, computed
CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.

Study groups in NCT02236546
Study group	Role	What they receive
FDG-PET/CT	Experimental	Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data. Receives: Diagnostic Test: [18F]fluorodeoxyglucose; Other: Molecular assays on biopsied tissue; Device: positron emission tomography; Device: computed tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST
The primary imaging metric is percent change in average FDG standardized uptake value (SUV) among the same target lesions between baseline and images acquired after completion of cycle 1. The relationship between tumor SUV change and size change will be assessed using standard linear regression.
Measured: Baseline to the completion of 6 courses of treatment

Secondary outcomes (3)

Objective Response (OR)
The ability of the percent change in average standardized FDG uptake to predict OR will be assessed using the proportional odds model.
Measured: Day 84
Progression-free Survival (PFS)
Cox (proportional hazards) regression will be used to assess the association between the percent change in average standardized FDG uptake and PFS.
Measured: Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years
Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation
The association between the changes in tumor FDG accumulation with a panel of immunohistochemical biomarkers will be assessed with the Spearman correlation statistic. 95% confidence intervals will be calculated for each variable. Paired changes in biomarker expression between biopsied (i.e., baseline) and biopsy samples will be compared using the nonparametric Wilcoxon signed rank test. Change in binary expression will be compared using McNemar's test. The Wilcoxon rank sum test (or Kruskal Wallis test for more than 2 groups) will be used to compare continuous and ordinal variables.
Measured: Baseline to day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Nov 2015

First posted10 Sep 2014 (estimated)
Study startMay 2012
Primary completionOct 2014
Study completionNov 2015

Why it stopped: loss of funding

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.
Other trials for Recurrent MelanomaStudies of the same condition, open and under way.
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 N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02236546
Sponsor's protocol ID: VICC MEL 1372
Other IDs: NCI-2014-00179, VICC MEL 1372, P30CA068485
Status last verified: Apr 2017
First submitted: 8 Sep 2014
Last updated: 13 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
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RecruitingPhase 1/2
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Recurrent or Metastatic Solid Tumors
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
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Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Recurrent Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: FDG-PET/CT as a Biomarker for Treatment Response in Advanced Melanoma
ClinicalTrials.gov ID: NCT02236546
Acronym / sponsor ID: VICC MEL 1372
Conditions: Recurrent Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma
Keywords: fluorodeoxyglucose, FDG, PET/CT, melanoma, imaging biomarkers, cancer imaging
Study type: Interventional
Recruitment status: TerminatedReason stopped: loss of funding
Enrolment: 3 participants (actual)
Lead sponsor: Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: May 2012
Primary completion: Oct 2014 (actual)
Study completion: Nov 2015 (actual)
First posted: 10 Sep 2014 (estimated)
Results: Posted 13 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To correlate treatment-induced changes in FDG uptake with changes in tumor size and progression-free survival (PFS) in patients receiving therapy for advanced melanoma.

II. To correlate treatment-induced changes in FDG uptake with changes in the activity and/or expression of available molecular biomarkers from patients receiving therapy for advanced melanoma.

OUTLINE:

Patients undergo FDG-PET/CT up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84).

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
FDG-PET/CT	Experimental	Diagnostic Test: [18F]fluorodeoxyglucose, Other: Molecular assays on biopsied tissue, Device: positron emission tomography, Device: computed tomographyPatients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects must have signed Institutional Review Board (IRB)-approved informed consent documentation
Subjects must be diagnosed with histologically proven stage IV (metastatic) melanoma or stage III with bulky disease which may or may not be amenable for surgery and are receiving therapy at present
Subjects must be scheduled to begin treatment through the Vanderbilt-Ingram Cancer Center (VICC) Melanoma Program; this will include patients receiving standard-of-care chemotherapy, targeted therapy, and/or immunotherapy, as well as patients accrued to VICC clinical trials for the study of investigational agents
Subjects must have measurable disease by CT or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; to comply with PET Response Criteria in Solid Tumors (PERCIST) criteria, subjects should have at least one lesion measuring at least 2 cm in the longest diameter

Key exclusion criteria (7 listed)

Subjects who are pregnant or nursing; urine pregnancy test/or serum human chorionic gonadotropin (HCG) will be performed on women of child bearing potential
Subjects who have experienced allergic or other adverse reactions in response to intravenous injection of fluorinated radiotracers and other contrast media used in PET/CT
Subjects incapable of giving informed written consent, for the following reasons:

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
[18F]fluorodeoxyglucoseAlso: 18-F-deoxy-glucose, 18-F-deoxyglucose, FDG, fluorodeoxyglucose F-18FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.	Diagnostic test	FDG-PET/CT
Molecular assays on biopsied tissueAlso: immunohistochemistry, genetic assay, laboratory biomarker analysis, molecular profilingCorrelative studies	Other	FDG-PET/CT
positron emission tomographyAlso: PET, PET scan, tomography, emission computedUndergo FDG-PET/CT	Device	FDG-PET/CT
computed tomographyAlso: CT, tomography, computedCT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.	Device	FDG-PET/CT

Primary outcome

Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST
Time frame: Baseline to the completion of 6 courses of treatment
The primary imaging metric is percent change in average FDG standardized uptake value (SUV) among the same target lesions between baseline and images acquired after completion of cycle 1. The relationship between tumor SUV change and size change will be assessed using standard linear regression.

3 secondary outcomes

Objective Response (OR)
Time frame: Day 84
Progression-free Survival (PFS)
Time frame: Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years
Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation
Time frame: Baseline to day 21

Results and safety

Results posted to the registry on 13 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FDG-PET/CT	3	3

Primary outcome: Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST

Time frame: Baseline to the completion of 6 courses of treatment

Population analysed: Due to loss of funding data were not collected

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FDG-PET/CT	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Recurrent Melanoma

Active, not recruitingPhase 3
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
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BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
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Active, not recruitingPhase 2
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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.

Tom Yankeelov, PhD principal investigator

Vanderbilt-Ingram Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 13 Apr 2017. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2017). 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?

Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST (time frame: Baseline to the completion of 6 courses of treatment). 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 NCT02236546.

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 13 Apr 2017.