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.

Phase I Study of Bendamustine and Fractionated Stereotactic Radiotherapy of Patients with 1 to 4 Brain Metastases from Solid Malignancies

Principal Investigator: John C. Grecula, MD

Condition: Brain metastases from solid tumors

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

Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiation therapy is able to deliver x-rays directly to the tumor and may cause less damage to normal tissues. This phase I trial is studying the side effects and best dose of bendamustine when given together with stereotactic radiation therapy in treating patients with brain metastases caused by solid tumors.

Primary Objective:

  • Determine the recommended phase II dose of bendamustine hydrochloride when administered in combination with stereotactic radiotherapy for the treatment of patients with 1 to 4 brain metastases from solid malignancies.

    Secondary Objectives:

  • Determine bendamustine pharmacokinetics and correlate this to bendamustine levels in brain metastases, brain margin, arachnoid, cerebral spinal fluid, and plasma acquired at the time of surgery.

  • Assessment of local control of brain metastases

Contact: Ohio State University Cancer Clinical Trial Matching Service • 866-627-7616 • osu@emergingmed.com

ClinicalTrials.gov Identifier: NCT00837928

A Phase IB/II Study of Gemcitabine and Docetaxel in Combination With Pazopanib for the Neoadjuvant Treatment of Soft Tissue Sarcoma

Principal Investigator: William Tap, MD

Conditions: Sarcoma, leiomyosarcoma, malignant peripheral nerve sheath tumor, malignant fibrous histiocytoma/undifferentiated pleomorphic sarcoma

Institution: Memorial Sloan-Kettering Cancer Center

This will be a single institution, single arm, phase IB/II trial to evaluate the clinical safety and efficacy of gemcitabine/docetaxel and pazopanib in the neoadjuvant treatment of soft tissue sarcoma (STS). Patients who meet the eligibility criteria will be treated with the combination therapy for 2 cycles and subsequently reevaluated for treatment effect. If no tumor progression is seen, patients will continue with 2 more cycles of treatment (total of 4 cycles). Those patients who experience disease progression will proceed directly to surgical resection. Following completion of neoadjuvant treatment, all patients will have definitive surgical resection. Following recovery from surgery, patients will proceed with adjuvant radiation therapy and then be followed for up to 2 years.

Primary Objectives:

Phase Ib:

  • Determine the maximum tolerated dose (MTD) of pazopanib in combination with gemcitabine and docetaxel in patients with STS

Phase II:

  • Assess the effectiveness of combination therapy in improving distant relapse-free survival of patients with STS from a historical control of 40%–60% at 2 years of follow up

Secondary Objectives:

Phase Ib:

  • Determine pathologic response to neoadjuvant therapy

Phase II:

  • Assess time to distant recurrence

  • Assess time to local recurrence

  • Assess pathologic response to combination therapy based on post-treatment specimen

Correlative Objectives:

  • Assess changes in receptor tyrosine kinase (RTK) expression using antibody array, the status of target RTK (VEGFR, c-KIT, PDGFR) expression by immunohistochemistry and assessment of pathway inhibition by Western blot

  • Assess changes in protein-coding genes, microRNA expression and genome-wide copy number using gene, microRNA, and CGH arrays

  • Assess the use of dynamic contrast-enhanced MRI in STS evaluation.

Contacts: William Tap, MD • 212-639-5720 Gary Schwartz, MD • 212-639-8324

ClinicalTrials.gov Identifier: NCT01418001

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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