PET/CT Evaluation of Subjects Treated on Surgery Branch Adoptive Cell Therapy Protocols
- Measure changes in metabolic activity at visceral sites during the acute treatment
phase of adoptive cell transfer (ACT) using positron emission tomography (PET)/CT
fusion imaging in patients with metastatic melanoma or renal cell cancer.
- Measure changes in metabolic activity at metastatic sites during the acute treatment
phase of ACT using PET/CT fusion imaging.
- Compare the changes in metabolic activity at visceral and metastatic sites in patients
treated with intravenous vs intra-arterial tumor-infiltrating lymphocyte infusions.
- Correlate response of individual metastases with these metabolic alterations.
OUTLINE: This is a pilot study. Patients are stratified according to treatment (intravenous
[IV] tumor-infiltrating lymphocytes [TIL] after a nonmyeloablative preparative regimen vs
intra-arterial [IA] TIL after a nonmyeloablative preparative regimen vs IV TIL after a
myeloablative preparative regimen with chemotherapy and total-body irradiation).
Patients undergo positron emission tomography with fludeoxyglucose F 18 (FDG-PET)/CT fusion
imaging at baseline (before starting TIL infusion), once between days 1-4 after TIL
infusion, and once between days 5-8 after TIL infusion.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Primary Purpose: Diagnostic
Metabolic activity at visceral sites
Richard E. Royal, MD, FACS
National Cancer Institute (NCI)
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|