Oncology Research Program

Highlights of the NCCN Oncology Research ProgramThe 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.Phase I Trial of Chemoradiation With Capecitabine and Vorinostat in Pancreatic CancerPrincipal Investigator: Emily Chan, MD, PhDCondition: Pancreatic cancer; periampullary adenocarcinomaInstitution: Vanderbilt-Ingram Cancer CenterThis is a phase I, dose-escalation trial studying the adverse events and best dose of vorinostat given with capecitabine and radiation therapy to patients with non-metastatic pancreatic cancer.Patients receive oral capecitabine twice daily and undergo high-dose hypofractionated radiotherapy once daily on days 1–5 and 8–12. Patients also receive oral vorinostat once daily on days 1–5, 8–12, 15–19, and 22–26 in the absence of disease progression or unacceptable toxicity. Blood samples are collected periodically for correlative laboratory studies. Patients also undergo diffusion-weighted MRI for analysis of in vivo tumor cellularity.Patients are evaluated for surgery 6 weeks...

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.

Phase I Trial of Chemoradiation With Capecitabine and Vorinostat in Pancreatic Cancer

Principal Investigator: Emily Chan, MD, PhD

Condition: Pancreatic cancer; periampullary adenocarcinoma

Institution: Vanderbilt-Ingram Cancer Center

This is a phase I, dose-escalation trial studying the adverse events and best dose of vorinostat given with capecitabine and radiation therapy to patients with non-metastatic pancreatic cancer.

Patients receive oral capecitabine twice daily and undergo high-dose hypofractionated radiotherapy once daily on days 1–5 and 8–12. Patients also receive oral vorinostat once daily on days 1–5, 8–12, 15–19, and 22–26 in the absence of disease progression or unacceptable toxicity. Blood samples are collected periodically for correlative laboratory studies. Patients also undergo diffusion-weighted MRI for analysis of in vivo tumor cellularity.

Patients are evaluated for surgery 6 weeks after chemoradiotherapy. Patients with resectable disease proceed to surgery; those with unresectable disease may receive oral vorinostat once daily and oral capecitabine twice daily on days 1–14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed up for 5 years after completion.

Primary Outcome Measures:

  • Determine the maximum tolerated dose of vorinostat when given in combination with capecitabine and radiotherapy.

Secondary Outcome Measures:

  • Safety, side effect profile, and response rate of combination vorinostat and capecitabine when used with radiation
  • Correlative studies: Whole-cell HDAC activity levels on peripheral blood mononuclear cells comparing pre- and posttreatment samples Assessment of chromatin structure and DNA damage in surgical samples In vivo imaging to assess tumor cellularity.

Contact: Clinical Trials Office, Vanderbilt-Ingram Cancer Center • 800-811-8480

ClinicalTrials.gov Identifier: NCT00983268

A Phase I/II Study of Temsirolimus + Weekly Paclitaxel + Carboplatin for Recurrent or Metastatic Head and Neck Squamous Cell Cancer

Principal Investigator: Matthew Fury, MD, PhD

Condition: Head and neck cancer

Institution: Memorial Sloan-Kettering Cancer Center

In phase I, the primary end point is to establish the phase II recommended dose for combination temsirolimus/weekly paclitaxel/carboplatin. Phase I features a standard 3 + 3 phase I dose escalation design, with up to 3 dose levels planned.

In phase II, the primary end point is to determine the objective response rate (CR or PR) after 2 cycles (∼ 6 wk) of treatment with combination temsirolimus/weekly paclitaxel/carboplatin as palliative therapy for recurrent or metastatic head and neck squamous cell cancer (HNSCC). A 2-stage design will be used.

Primary Outcome Measures:

  • Establish the phase II recommended dose for combination temsirolimus/weekly paclitaxel/carboplatin
  • Determine the objective response rate (CR or PR) after 2 cycles of treatment with combination temsirolimus/weekly paclitaxel/carboplatin as palliative therapy for recurrent or metastatic HNSCC

Secondary Outcome Measures:

  • Establish the safety of temsirolimus/weekly paclitaxel/carboplatin
  • Estimate median overall survival
  • Identify potential molecular markers of resistance to mTOR inhibition in tumor specimens obtained as part of routine clinical care

Contacts: Matthew Fury, MD, PhD • 212-639-3049

David Pfister, MD • 212-639-8235

ClinicalTrials.gov Identifier: NCT01016769.

Phase I Study of Bendamustine With Concurrent Whole Brain Radiation Therapy in Patients With Brain Metastases From Solid Tumors

Principal Investigator: Edward Pan, MD

Condition: Brain metastases

Institution: H. Lee Moffitt Cancer Center & Research Institute

Study patients will receive a weekly dose of intravenous bendamustine with whole-brain radiation therapy (WBRT) for 3 weeks, and a fourth dose 1 week after completion of WBRT. The first dose will be given when WBRT is started. When the maximum tolerated dose (MTD) has been determined, 3 to 6 study patients will be enrolled to receive a lumbar puncture immediately after the fourth bendamustine dose to determine whether bendamustine penetrates into the cerebrospinal fluid (CSF). The MTD has yet to be determined.

Primary Objectives:

  • Determine the MTD of bendamustine with concurrent WBRT
  • Determine the plasma pharmacokinetics of bendamustine in study patients
  • Determine the presence of bendamustine in CSF of study patients

Secondary Objectives:

  • Determine 6-month progression-free survival of study patients
  • Determine overall survival of study patients
  • Assess neurocognitive function and quality of life throughout the study course

Contact: Pam A. Smith, CCRP • 813-745-3951 • pam.smith@moffitt.org

ClinicalTrials.gov Identifier: NCT00879073

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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