FDG-PET in Advanced Melanoma

Stage IV Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02236546
• Other study ID #: VICC MEL 1372
• Secondary ID: NCI-2014-00179VI
• Status: Terminated
• Phase: N/A
• First received: September 8, 2014
• Last updated: April 12, 2017
• Start date: May 2012
• Est. completion date: November 2015

Study information

• Verified date: April 2017
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. FDG-PET/CT of advanced melanoma before, during, and after treatment may improve methods for predicting which patients may benefit from therapy.

Description:

PRIMARY OBJECTIVES:

I. 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Melanoma
• Recurrent Melanoma
• Stage IIIA Melanoma
• Stage IIIB Melanoma
• Stage IIIC Melanoma
• Stage IV Melanoma

Intervention

Diagnostic Test:
• [18F]fluorodeoxyglucose
FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.

Other:
• Molecular assays on biopsied tissue
Correlative studies

Device:
• positron emission tomography
Undergo FDG-PET/CT
• computed tomography
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.

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to the completion of 6 courses of treatment
Secondary	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.	Day 84
Secondary	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.	Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years
Secondary	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.	Baseline to day 21