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.
