Oncology Research Program

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.

NCCN studies funded through the grant mechanism are highlighted below.

A Phase 2 Study of Tivozanib in Recurrent Glioblastoma

Principal Investigator: Elizabeth R. Gerstner, MD

Condition: Glioblastoma

Institution: Massachusetts General Hospital

This is an open-label, nonrandomized, phase 2 study with oral tivozanib in adult patients with recurrent glioblastoma (GBM). Eligible patients will receive tivozanib at a dose of 1.5 mg daily by mouth on the first 3 weeks of every 4-week cycle. One cycle is defined as 28 days. There is no maximal length of therapy. Eighteen evaluable patients will be enrolled in this study. Patients will be followed with serial neurologic and physical examinations, MRI evaluations, and serum biomarker assessments. All patients will be treated until radiographic or clinical evidence is seen of disease progression or unacceptable toxicity. Patients may withdraw from the study at any time.

Primary Objective:

  • Determine the proportion of patients with GBM alive and progression free 6 months after start of tivozanib therapy

Secondary Objectives:

  • Determine the safety of tivozanib in this patient population
  • Determine the progression-free and overall survivals of patients with recurrent GBM treated with tivozanib
  • Determine the radiographic response using standard contrast-enhanced cranial MRI techniques
  • Assess the steroid dose/duration before, during, and after treatment with tivozanib
  • Assess the correlation of treatment outcome to specific serial circulating cytokines/receptors (eg, VEGF, PlGF, bFGF, SDF1α, Il-1b, Il-6, Il-8, TNF-α, collagen 4, Ang1, Ang2, thrombospondin, sVEGFR1) and cell populations (CPCs, CECs, VEGFR2+ monocytes) to determine whether these markers can be predictive of response to tivozanib (exploratory)
  • Assess the effect of tivozanib on GBM tumor growth by using physiologic MRI parameters of perfusion, permeability, oxygenation status, diffusion, kurtosis, functional connectivity, and resting-state networks

Contact: Elizabeth Gerstner, MD • 617-724-8770 • egerstner@partners.org

ClinicalTrials.gov Identifier: NCT01846871

Multicenter Phase 1b/2 Study of Tivozanib in Patients With Advanced Inoperable Hepatocellular Carcinoma

Principal Investigator: Renuka Iyer, MD

Conditions: Adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, and recurrent adult primary liver cancer

Institution: Roswell Park Cancer Institute

This is a phase lb/2 study of tivozanib in patients with advanced inoperable hepatocellular carcinoma (HCC). Based on monotherapy tolerability data of tivozanib from 14 studies, an oral dose of 1.5 mg daily has been recommended for phase 2 testing. Because tivozanib has not been tested in patients with HCC, and because patients with HCC who are candidates for systemic therapies tend to have Child-Pugh class A or early B cirrhosis, this study will start with a phase 1 dose-escalation study. The phase lb portion of the study follows a modified 3 + 3 design. Typical 3 + 3 studies start at the lowest dose. This modified design starts patients at the middle dose. The first 3 patients will be treated with a 1-mg oral once-daily dosage. Depending on observed toxicity rates, the dose may be deescalated to 0.5 mg or escalated to 1.5 mg. The dose of 1.5 mg daily is expected to be the recommended phase 2 dose. The standard 3 + 3 dose (de) escalation rules will be followed. Dose level will be considered tolerable after completion of the first cycle of treatment.

Primary Objective:

  • Progression-free survival (PFS) at 24 weeks in patients with advanced HCC

Secondary Objectives:

  • Determine the safety of tivozanib in HCC
  • Determine the overall survival and clinical benefit rate (complete response, partial response, and stable disease) based on RECIST criteria
  • Determine the steady-state pharmacokinetics and soluble vascular endothelial growth factor receptor 2 baseline/change with tivozanib, and use modeling to correlate exposure with biomarker change and the primary outcome measure of PFS
  • Determine the change in viral load (hepatitis B virus [HBV] and hepatitis C virus [HCV]) during therapy in patients with HBV- or HCV-associated HCC

Contact: Roswell Park • 877-275-7724 • ASKRPCI@roswellpark.org

ClinicalTrials.gov Identifier: NCT01835223

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.

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