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.

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

Randomized, Phase II Trial of AZD6244 Alone and AZD6244 Plus Temsirolimus for Soft-Tissue Sarcomas

Principal Investigator: Warren A. Chow, MD

Condition: Sarcoma

Institutions: City of Hope Comprehensive Cancer Center; USC/Norris Comprehensive Cancer Center and Hospital; University of California Davis Cancer Center; City of Hope Medical Group, Inc.; Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center; and UPMC Cancer Centers

The MEK inhibitor, AZD6244, and the mTOR inhibitor, temsirolimus, may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. Whether AZD6244 with temsirolimus is more effective than AZD6244 alone is not yet known.

This multi-institutional, randomized, phase II trial is studying AZD6244 with or without temsirolimus in treating patients with metastatic, recurrent, or locally advanced soft tissue sarcoma that cannot be removed by surgery.

Primary Objective:

  • Compare the progression-free survival (PFS) of patients with metastatic, recurrent, or locally unresectable soft tissue sarcomas treated with MEK inhibitor AZD6244 with versus without temsirolimus

Secondary Objectives:

  • Determine rates of apoptosis, autophagy, and proliferation by immunohistochemistry in tumor and surrogate skin tissue biopsies (exploratory)
  • Assess activation status of Akt, 5E-BP1, eIF-4G, and S6K in tumor biopsy samples and surrogate skin tissue biopsy samples (exploratory)
  • Assess inhibition of activated ERK1/2 in stimulated peripheral blood mononuclear cells (exploratory)
  • Assess response by Choi criteria
  • Compare response and 4-month PFS rates
  • Determine toxicity of these regimens

Contact: Clinical Trials Office, City of Hope Comprehensive Cancer Center • 800-826-4673 • becomingapatient@coh.org

ClinicalTrials.gov Identifier: NCT01206140

Phase I Trial of Vorinostat in the Treatment of Advanced Oropharyngeal Carcinoma of the Head and Neck

Principal Investigator: Theodoros N. Teknos, MD

Conditions: Stage III and IV squamous cell carcinoma of the oropharynx

Institution: The Ohio State University Comprehensive Cancer Center-James Cancer Hospital and Solove Research Institute

Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Vorinostat together with chemotherapy and radiation therapy may kill more tumor cells.

This phase I trial is studying the side effects and best dose of vorinostat together with cisplatin and radiation therapy in treating patients with stage III or IVa squamous cell cancer of the oropharynx that is either unresectable or borderline resectable.

Primary Outcome Measure:

  • Maximum tolerated dose of vorinostat in combination with concurrent chemoradiation therapy

Secondary Outcome Measures:

  • Tumor responses to vorinostat alone or vorinostat with chemoradiation
  • Complete response rate
  • Overall survival
  • Progression-free survival
  • Relationship between vorinostat therapy and tumor suppressor genes product assessed by Fas and FasL protein expression level in tumor and the normal mucosa
  • HPV-specific T-cell in patients with HPV-positive tumors

Contact: Theodoros N. Teknos, MD • 614-293-8074 • Ted.Teknos@osumc.edu

ClinicalTrials.gov Identifier: NCT01064921

Phase II Trial of Abraxane Plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding from VEGF-Directed Therapies

Principal Investigator: Gregory Otterson, MD

Condition: Advanced non-small cell lung cancer

Institution: The Ohio State University Comprehensive Cancer Center-James Cancer Hospital and Solove Research Institute

Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously over 30 minutes and carboplatin intravenously over 1 to 2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Biomarkers (archival tissue, serum and blood) will be studied.

Primary Outcome Measures:

  • Response rate as defined by RECIST

Secondary Outcome Measures:

  • Progression-free survival
  • Overall survival

Contact: Gregory A. Otterson, MD • 866-627-7616 • osu@emergingmed.com

ClinicalTrials.gov Identifier: NCT00729612

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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