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 II Study of Bendamustine in the Treatment of Recurrent High-Grade Gliomas (Anaplastic Gliomas and Glioblastoma)Principal Investigator: Marc Chamberlain, MDCondition: Anaplastic glioma; glioblastoma (arm closed)Institution: Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, University of Washington, Seattle, WAThis phase II trial is studying how well bendamustine hydrochloride works in treating patients with recurrent or progressive anaplastic glioma or glioblastoma multiform. (Please note: the glioblastoma arm of this study is closed.)Primary Outcome Measures: Six month progression-free survival rate Secondary Outcome Measures: Best overall response Progression-free survival Toxicity Survival Contact: Sandra K. Johnston, RN, PhD • 206-288-6365ClinicalTrials.gov Identifier: NCT00823797Phase I/II Trial of Torisel and Liposomal Doxorubicin in Patients With Advanced Soft Tissue and Bone SarcomasPrincipal Investigator: David Loeb, MD,...

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 II Study of Bendamustine in the Treatment of Recurrent High-Grade Gliomas (Anaplastic Gliomas and Glioblastoma)

Principal Investigator: Marc Chamberlain, MD

Condition: Anaplastic glioma; glioblastoma (arm closed)

Institution: Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, University of Washington, Seattle, WA

This phase II trial is studying how well bendamustine hydrochloride works in treating patients with recurrent or progressive anaplastic glioma or glioblastoma multiform. (Please note: the glioblastoma arm of this study is closed.)

Primary Outcome Measures:

  • Six month progression-free survival rate

Secondary Outcome Measures:

  • Best overall response

  • Progression-free survival

  • Toxicity

  • Survival

Contact: Sandra K. Johnston, RN, PhD • 206-288-6365

ClinicalTrials.gov Identifier: NCT00823797

Phase I/II Trial of Torisel and Liposomal Doxorubicin in Patients With Advanced Soft Tissue and Bone Sarcomas

Principal Investigator: David Loeb, MD, PhD

Condition: Sarcoma

Institution: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD

Description: The effectiveness of treatments for recurrent sarcomas is quite limited. One hypothesis to explain the refractory nature of recurrent sarcomas is the existence of chemotherapy-resistant sarcoma stem cells.

Primary Outcome Measures:

  • Incidence of dose limiting toxicities

  • Objective response rate

Secondary Outcome Measures:

  • Describe the pharmacokinetics of Torisel when administered with liposomal doxorubicin

  • Determine progression-free survival

  • Determine time to clinical benefit rate

  • Overall survival

  • Assess the activity of the mTOR signaling pathway before and after therapy with Torisel and liposomal doxorubicin

  • Measure the proportion of cells with stem cell properties in tumors before and after treatment with Torisel and liposomal doxorubicin

Contact: Margaret F. Ferreira, RN, BSN • 410-955-7349 • mfogle1@jhmi.edu; Tammy Scott, RN, BSN • 410-614-5990 • scottta@jhmi.edu ClinicalTrials.gov Identifier: NCT00949325

Phase II Study Evaluating the Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer

Principal Investigator: Eric Sherman, MD

Condition: Thyroid cancer

Institution: Memorial Sloan-Kettering Cancer Center, New York, NY

This is a phase II study to evaluate the efficacy of the combination sorafenib with temsirolimus in patients with thyroid cancer of follicular cell origin (e.g., papillary, follicular, Hurthle cell).

Primary Outcome Measures:

  • Determine the objective response rate of the combination sorafenib and temsirolimus in I-131 refractory thyroid cancer

Secondary Outcome Measures:

  • Evaluate if the presence of BRAF mutations, with or without concomitant mutations in the PI3K AKT, mTOR pathway, predict response to therapy

  • Determine progression-free survival under the combination sorafenib and temsirolimus in I-131 refractory thyroid cancer

  • Evaluate safety and tolerability for the combination sorafenib and temsirolimus in I-131 refractory thyroid cancer

Contact: Eric Sherman, MD • 212-639-5070

Matthew Fury, MD, PhD • 212-639-3049

ClinicalTrials.gov Identifier: NCT01025453

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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