Overview

This trial is active, not recruiting.

Conditions melanoma, renal cell carcinoma (rcc), non-small cell lung cancer (nsclc)
Treatment pet/ct imaging with [18f] 2-deoxy-2-(18f)fluoro-d-glucose (fdg)
Phase phase 0
Sponsor Sidney Kimmel Comprehensive Cancer Center
Start date April 2012
End date December 2015
Trial size 20 participants
Trial identifier NCT01666353, J1208, NA_00049919

Summary

This study aims to develop methods for quantitative imaging of solid tumors in patients who are receiving immunotherapies that have a delayed mechanism of action.

PET imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG) is a potent diagnostic tool and is able to detect melanomas and other tumors, some of which are undetectable by CT. FDG PET is now used commonly in detecting melanoma in humans as melanomas quite consistently have high glucose metabolism. PET with FDG can image the response of tumors to therapy, but has not been extensively evaluated in melanoma nor in immunotherapy for melanoma. PET has been shown to be highly predictive of outcomes of patients following radioimmunotherapy of lymphoma, and has shown changes in tumor glycolysis as early as 7 days after immunotherapy initiation.

In order to develop PET/CT as a tool to detect early evidence of response in patients with solid tumors receiving immune checkpoint blockade, investigators propose to perform PET/CT imaging prior to therapy, again between days 21 and 28, and finally at 4 months post-treatment initiation. Each scan will be assessed qualitatively and quantitatively. Investigators will use the PERCIST criteria to determine peak and maximum standardized uptake values corrected for lean body mass (SUL) in tumor, tumor volumes, and tumor total glycolytic volumes, and will use CT from PET/CT to measure tumor size by immune RECIST criteria. (See section on Outcome Evaluation below.) Investigators will assess whether early changes in tumor metabolism seen on FDG PET are predictive of progression free and overall survival outcomes. Through these systematic pilot studies, investigators hope to better link FDG PET measurements to individual patient responses to immune checkpoint blockade therapy and better understand and refine this emerging and often effective therapeutic approach.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Adult patients, with documented metastatic melanoma, RCC or NSCLC, about to initiate any line of immune checkpoint blockade therapy will receive a FDG PET scan during mid treatment to check for change in disease.
pet/ct imaging with [18f] 2-deoxy-2-(18f)fluoro-d-glucose (fdg)
PET/CT imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG) is a potent diagnostic tool and is able to detect melanomas and other tumors, some of which are undetectable by CT.

Primary Outcomes

Measure
Compare FDG PET-based qualitative and quantitative tumor response assessment with standard CT immune RECIST criteria
time frame: 6 months after completion of standard of care treatment

Secondary Outcomes

Measure
Assess the use of FDG PET as a non-invasive imaging method to detect early evidence of organ inflammation
time frame: 6 months after completion of standard of care treatment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Age ≥18 years 2. Any subject with documented metastatic melanoma, RCC or NSCLC. 3. Subjects must be scheduled to receive therapy, or received only one dose, with an anti-neoplastic agent that works by immune checkpoint blockade such as ipilimumab/Yervoy (anti-CTLA-4), MDX-1106/BMS-936558 (anti-PD-1) or MDX-1105/BMS-936559 (anti-B7-H1) mAbs. 4. Subjects must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as >10 mm with spiral CT scan. Exclusion Criteria: 1. Patient is unable to provide informed consent 2. Patient is pregnant 3. Patient enrollment on research protocol which includes an additional mid-therapy investigational FDG PET/CT at approximately month from start of therapy.

Additional Information

Official title PET Quantitative Assessments of Solid Tumor Response to Immune Checkpoint Blockade Therapy
Principal investigator Evan Lipson, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.