Clinical trial NCT02236546: FDG-PET in Advanced Melanoma
Official title: FDG-PET/CT as a Biomarker for Treatment Response in Advanced Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-09-10
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST
timeFrame: Baseline to the completion of 6 courses of treatment
Secondary outcomes:
measure: Objective Response (OR)
timeFrame: Day 84
measure: Progression-free Survival (PFS)
timeFrame: Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years
measure: Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation
timeFrame: Baseline to day 21
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Tom Yankeelov, PhD
role: PRINCIPAL_INVESTIGATOR
References: