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-sponsored studies funded through the grant mechanism are highlighted below.

Phase II Study of Ofatumumab as Front-Line Treatment in Elderly, Unfit Patients With Chronic Lymphocytic Leukemia

Principal Investigator: Alessandra Ferrajoli, MD, BS Condition: Chronic lymphocytic leukemia (CLL)

Institution: The University of Texas MD Anderson Cancer Center

Ofatumumab, a novel anti-CD20 antibody, has been tested in various hematologic malignancies and is currently FDA-approved for treatment of patients with CLL that is relapsed/refractory to prior treatments with fludarabine and alemtuzumab. The goal of this clinical research study is to learn if ofatumumab can help to control CLL. The safety of this drug will also be studied.

Primary Objective:

  • Evaluate the overall response rate of ofatumumab in the upfront setting in elderly, unfit patients with CLL

Secondary Objectives:

  • Determine the overall survival with ofatumumab in the upfront setting in elderly, unfit patients with CLL
  • Evaluate the complete response rate and time to progression after repeated doses of ofatumumab in elderly, unfit patients with CLL
  • Determine the plasma levels of ofatumumab in elderly, unfit patients with CLL
  • Evaluate predictive capability of miRNAs detection in plasma samples

Contact: Alessandra Ferrajoli, MD, BS • 713-792-2063 • aferrajo@mdanderson.org

ClinicalTrials.gov Identifier: NCT01444716

Phase I Study of Perifosine With Temsirolimus for Recurrent Pediatric Solid Tumors

Principal Investigator: Ira Dunkel, MD

Condition: Pediatric solid tumors

Institution: Memorial Sloan-Kettering Cancer Center This study is testing the safety and effectiveness of perifosine in combination with temsirolimus in children with solid tumors. Neither drug is currently part of the standard treatment of solid tumors in children, but new insight is that, if given together, perifosine and temsirolimus may work to stop the growth of and possibly shrink solid tumors. Patients are currently being treated at the fourth and final planned dose level.

Primary Outcome Measures:

  • Maximum tolerated dose (MTD) of perifosine + temsirolimus combination in children with cancer

Secondary Outcome Measures:

  • Determine whether pharmacokinetic serum levels of both perifosine and temsirolimus correlate with toxicity
  • Record preliminary data on the efficacy of the perifosine + temsirolimus combination
  • If previously resected tissue is available, determine whether molecular features predict response including, elevated PI3K/AKT/mTOR signaling, elevated RAS/MAPK signaling, cell cycle markers

Contact: Ira Dunkel, MD • 212-639-2153

Stephen Gilheeney, MD • 212-639-3973

ClinicalTrials.gov Identifier: NCT01049841

A Multi-Institution Phase II Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Cancer

Principal Investigator: Alan Ho, MD, PhD

Condition: Head and neck cancer

Institution: Memorial Sloan-Kettering Cancer Center

The purpose of this study is to find out if the experimental drug pralatrexate with the vitamins folic acid and vitamin B12 might be an effective treatment for head and neck cancer in patients previously treated with chemotherapy. This study is being performed because methotrexate has been used for a long time to treat patients with head and neck cancer. Pralatrexate was designed by scientists to be a new drug that works better than methotrexate. Laboratory studies have shown that pralatrexate works better than methotrexate at killing cancer cells. Pralatrexate has already been studied in patients with other types of cancers, such as lymphoma and lung cancer. The results from those studies were promising.

Primary Outcome Measures:

  • Determine the overall response rate (CR+PR)

Secondary Outcome Measures:

  • Determine the best overall response rate at the end of treatment with pralatrexate
  • Estimate median progression free survival (PFS)
  • Estimate median overall survival (OS)
  • Quantify the mRNA transcript levels of reduced folate carrier (RFC-1) in study patients and correlate to best overall response with pralatrexate
  • Evaluate the impact of pralatrexate on circulating endothelial cells (CECs) and circulating progenitor cells (CPCs) and correlate to best overall response with pralatrexate

Contact: Alan Ho, MD, PhD • 212-639-3311

ClinicalTrials.gov Identifier: NCT01183065

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 http://www.nccn.org/clinical_trials/clinicians.asp.

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