Biomarkers Consortium - Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) Lung and Lymphoma

Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) Lung and Lymphoma studies are being conducted under the auspices of the Biomarkers Consortium. The research assesses the use of FDG-PET as a companion biomarker study in two separate National Cancer Institute (NCI) Cooperative Group clinical trials conducted in non-Hodgkin’s lymphoma (CALGB 50303) and non-small cell lung cancer (ACRIN 6678). The overall goal of the FDG-PET Lung and Lymphoma Projects is to determine the linkage of FDG-PET to the effect of conventional cytotoxic drugs in clinical outcome and survival in these two tumor types. The team is working with the FNIH to combine the early results of these two trials with additional data from industry trials to support additional analysis related to regulatory impact with the Food and Drug Administration (FDA) in collaboration with the Radiological Society of North America (RSNA)-sponsored Quantitative Imaging Biomarker Alliance (QIBA).

Goals

  • The overall goal of the FDG-PET Lung and Lymphoma Projects is to determine the linkage of FDG-PET to the effect of conventional cytotoxic drugs in clinical outcome and survival in these two tumor types.
  • The primary endpoint of the FDG-PET Lung Project is the prediction of overall patient survival by monitoring changes in tumor metabolic activity during the first chemotherapy cycle.
  • The primary objective of the FDG-PET Lymphoma Project is to identify biomarkers of response to chemotherapy by FDG-PET imaging that are predictive of complete clinical remissions and survival in subjects with stage I (mediastinal), II, III or IV untreated Diffuse Large B-Cell Lymphomas (DLBCL).

Results & Accomplishments

In qualification discussions with FDA.

Scientific Publications

Progress and Promise of FDG-PET Imaging for Cancer Patient Management and Oncologic Drug Development. Kelloff G, Hoffman J, Johnson B, Scher H, Siegel B, Cheng E, Cheson B, O’Shaughnessy J, Guyton K, Mankoff D, Shankar L, Larson S, Sigman C, Schilsky R, Sullivan D. Clin Cancer Res 2005; 11(8) April 15, 2005.

Partners

Public-Sector Partners:
National Cancer Institute (NCI)
U.S. Food and Drug Administration (FDA)

Private-Sector Partners:
Amgen, Inc.*
AstraZeneca Pharmaceuticals LP*
Bristol-Myers Squibb Company*
GlaxoSmithKline*
Johnson & Johnson*
Merck Sharp & Dohme Corp.*
Pfizer Inc*
Wyeth Nutrition*

Academic Partners:
Brown University
Duke University
Georgetown University
Karmanos Cancer Institute
The Leukemia & Lymphoma Society
Mallinckrodt Institute of Radiology
Memorial Sloan Kettering Cancer Center
University of California, Los Angeles
University of Chicago
University of Iowa
University of Pennsylvania

*Provided financial or in-kind support for this program.
 

FNIH Contact

Stacey J. Adam, PhD, Director, Cancer; sadam@fnih.org