Highlights of the NCCN Oncology Research Program
The NCCN Oncology Research Program (ORP) strives to improve the quality of life for patients and reduce cancer-related deaths by advancing cancer therapies through research. Since the program's establishment in 1999, the NCCN ORP has brought millions of dollars in research grants to investigators at NCCN Member Institutions. Research grants are provided to NCCN through collaborations with pharmaceutical and biotechnology companies; these grants are in turn used to support scientifically meritorious cancer research efforts.
NCCN ORP studies typically explore new avenues of clinical investigation and seek answers to important cancer-related questions. All studies are approved and funded through a scientific peer-review process and are overseen by the ORP.
An NCCN study funded through the grant mechanism are highlighted below.
A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy for First-Line Treatment of Unresectable Hepatocellular Carcinoma
Co-Principal Investigators: Jessica Frakes, MD, and Richard Kim, MD
Condition: Unresectable hepatocellular carcinoma
Institution: Moffitt Cancer Center
This is a phase I study evaluating the combination of stereotactic body radiation therapy (SBRT) with sorafenib/bavituximab for multifocal, unresectable hepatocellular carcinoma (HCC) using a standard 3+3 design for dose escalation. The primary objective is to evaluate the safety and tolerability of bavituximab/sorafenib in combination with SBRT in patients with advanced HCC and determine the maximum tolerated dose and recommended dose for cohort expansion for this combination regimen. SBRT will be given first, and then after a 1-week break, sorafenib and bavituximab will be started concurrently.
Primary Objective:
Evaluate the toxicity and safety of combination treatment with SBRT and sorafenib/bavituximab in patients with multifocal, unresectable HCC
Secondary Objectives:
Determine tumor response to the combination
Determine progression-free survival following SBRT and sorafenib/bavituximab
Determine overall survival following SBRT and sorafenib/bavituximab
Exploratory Objective:
To use the radiosensitivity index, 12-gene chemokine signature, and plasma levels of circulating cytokines and correlate with therapeutic response and measure β2-GP1 and phosphatidylserine-exosome levels
Contacts: Taymeyah Al-Toubah • taymehah.altoubah@moffitt.org
Richard Kim, MD • richard.kim@moffitt.org
Jessica Frakes, MD • jessica.frakes@moffitt.org
ClinicalTrials.gov Identifier: NCT02989870
The goal of the Highlights of the NCCN Oncology Research Program (ORP) is to provide readers with more information on the ORP, including studies currently accruing patients.
For more information on specific trials, including patient selection criteria, please use the contact information listed with each study.
For more information on the NCCN ORP, including a complete detailing of the clinical studies currently underway at NCCN Member Institutions, please access the NCCN ORP pages at NCCN.org/clinical_trials/clinicians.asp.
