Recurrent Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma
Conditions
Keywords
fluorodeoxyglucose, FDG, PET/CT, melanoma, imaging biomarkers, cancer imaging
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).
Interventions
DIAGNOSTIC_TEST[18F]fluorodeoxyglucose
FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
OTHERMolecular assays on biopsied tissue
Correlative studies
DEVICEpositron emission tomography
Undergo FDG-PET/CT
DEVICEcomputed 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.
Sponsors
National Cancer Institute (NCI)
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response (OR) | Day 84 | The ability of the percent change in average standardized FDG uptake to predict OR will be assessed using the proportional odds model. |
| Progression-free Survival (PFS) | Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years | Cox (proportional hazards) regression will be used to assess the association between the percent change in average standardized FDG uptake and PFS. |
| Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation | Baseline to day 21 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited to this trial at Vanderbilt Medical Center in Nashville, TN from November 2014 to November 2015
Pre-assignment details
Four people consented to participate in this trial, one was determined to be ineligible.
Participants by arm
| Arm | Count |
|---|---|
| FDG-PET/CT 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.
\[18F\]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
Molecular assays on biopsied tissue: Correlative studies
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. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | FDG-PET/CT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 57.66667 Years STANDARD_DEVIATION 19.85783 |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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.
Time frame: Baseline to the completion of 6 courses of treatment
Population: Due to loss of funding data were not collected
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.
Time frame: Baseline to day 21
Population: Due to loss of funding data were not collected
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.
Time frame: Day 84
Population: Due to loss of funding data were not collected
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 frame: Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years
Population: Due to loss of funding data were not collected