Organization of the ETCTN

The Experimental Therapeutics Clinical Trials Network (ETCTN) is designed to be a collaborative network made up of the following grant and contract components:

ETCTN Lead Academic Organizations (LAOs) leading and participating in trials
ETCTN Network Pharmacokinetic (PK) Resource Laboratories conducting PK studies in appropriate trials
NCI's Early-Phase and Experimental Clinical Trials (EET) Biobank facilitating biospecimen collection and use
NCI-supported National Clinical Laboratory Network (NCLN) and other resources for conducting correlative studies and assessing translational endpoints
Centralized NCI support for key scientific, administrative, and regulatory functions
Substantial NCI involvement in scientific and programmatic stewardship of these cooperative agreements

Dr. Lori Henderson is the Program Director and Dr. Lorraine Pelosof is the Scientific Officer for the ETCTN. NCI experts in CTEP's Investigational Drug Branch provide agent-specific oversight of trials run by the ETCTN.

ETCTN Infrastructure and Available Agents

ETCTN Overview

The ETCTN and its supporting infrastructure provides an established system for early-stage clinical development of novel anticancer treatments that are then evaluated in clinical trials conducted under DCTD/CTEP Investigational New Drug (IND) applications in national, high-priority areas of unmet medical need.

ETCTN clinical trials determine the safety of IND agent drug combinations, find early signals of clinical activity of these agents in targeted populations, and perform in-depth analysis of biomarkers of response and resistance.

To support these trials, CTEP has established resource laboratories for pharmacokinetic (PK) studies, as well as the NCI National Clinical Laboratory Network (NCLN), which supports genomics-based and pharmacodynamic studies.

Learn about how a CTEP-supported trial in the ETCTN goes from an idea to results.

ETCTN Available Agents

DCTD/CTEP currently holds approximately 210 INDs for investigational oncology agents/combinations which involve about 100 collaborative agreements with pharmaceutical/biotechnology companies. Agents available under CTEP agreements for evaluation include, but are not limited to, small molecules, immune-oncology agents, antibodies, targeted toxins, oligonucleotides, and gene transfer agents.

Through this program, hundreds of agents and agent combinations have been made available for collaborative agent development within CTEP. Effective development of these agents requires a systematic development plan for phase 1 and pilot trials, followed by phase 2 trials that, it is hoped, will conclude with definitive evaluation in phase 3 trials.

ETCTN Lead Academic Organizations (LAOs)

The ETCTN includes eight grantee Lead Academic Organizations (LAOs). LAOs may include Affiliated Organizations (AOs) that partner with the LAO under the LAO's leadership and oversight to develop and lead trials and enroll patients to trials. Additional sites that are Integrated Components (ICs) of the LAO or AO governance may also participate and enroll patients.

All LAOs lead and participate in a broad portfolio of ETCTN trials.

ETCTN Lead Academic Organization (LAO) Grantee	LAO Affiliated Organization(s) (AOs)
City of Hope Comprehensive Cancer Center LAO	Case Western Reserve Stanford Cancer Institute University of California Davis Comprehensive Cancer Center USC / Norris Comprehensive Cancer Center University of Chicago
Dana-Farber - Harvard Cancer Center LAO	Beth Israel Deaconess Medical Center Mayo Clinic Massachusetts General Hospital NYU Langone
JHU Sidney Kimmel Comprehensive Cancer Center LAO	Emory University MedStar Georgetown University Hospital Memorial Sloan Kettering Cancer Center Thomas Jefferson University of Colorado Hospital University of Maryland/Greenebaum Cancer Center University of Virginia Cancer Center University of Wisconsin Carbone Cancer Center Wake Forest University Health Sciences
Ohio State University Comprehensive Cancer Center LAO	Huntsman Cancer Institute/University of Utah NYP/Weill Cornell Medical Center University of Kentucky/Markey Cancer Center UNC Lineberger Comprehensive Cancer Center
University Health Network Princess Margaret Cancer Center LAO	Moffitt Cancer Center Northwestern University Rutgers Cancer Institute of New Jersey University of Miami Miller School of Medicine — Sylvester Cancer Center UT Southwestern/Simmons Cancer Center Virginia Commonwealth University/Massey Cancer Center
University of Texas MD Anderson Cancer Center LAO	University of Texas Medical Branch University of Texas Austin University of Texas Health Sciences in San Antonio
UPMC Hillman Cancer Center LAO	Montefiore Medical Center Oregon Health Sciences Center UC Irvine Health/Chao Family Comprehensive Cancer Center University of Cincinnati Cancer Center
Yale University Cancer Center LAO	Memorial Hospital East NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center UC San Diego Moores Cancer Center University of Florida - Gainesville University of Kansas Cancer Center University of Oklahoma Health Sciences Center Vanderbilt University/Ingram Cancer Center Washington University School of Medicine

Investigational Drug Steering Committee

The NCI Coordinating Center for Clinical Trials (CCCT) convenes scientific steering committees, which are composed of leading cancer experts, biostatisticians, translational scientists, and patient advocates, as well as NCI senior investigators.

The Investigational Drug Steering Committee (IDSC) collaborates with the NCI in the design and prioritization of early phase drug development trials carried out within the ETCTN.