Oncology Research Program

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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.

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

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

The phase I portion of the study has been completed. In phase II of the study, the primary end point is to determine the objective response rate (complete response [CR] or partial response [PR]) after 2 cycles (approximately 6 weeks) of treatment with the combination of 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 for Phase II:

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

Secondary Outcome Measures:

  • Establish the safety of temsirolimus + weekly paclitaxel + carboplatin

  • Eestimate median overall survival

  • Identify potential molecular markers of resistance to mTOR inhibition in tumor specimens obtained as part of routine clinical care

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

David Pfister, MD • 212-639-8235

ClinicalTrials.gov Identifier: NCT01016769

A Phase II Study of Ofatumumab–High-Dose Methylprednisolone Followed by Ofatumumab-Alemtuzumab in 17p Deletion CLL

Principal Investigator: Jennifer R. Brown, MD, PhD

Condition: Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)

Institution: Dana Farber Cancer Institute

This study will be a parallel 2-arm phase II multicenter study in participants with 17p deletion CLL who require therapy. Participants will be assigned to 1 of 2 treatment cohorts based on whether they are previously untreated or have had any prior systemic therapy for CLL/SLL. Therapy is the same in both cohorts and will include ofatumumab with high-dose methylprednisolone (HDMP) for 2 to 4 cycles (Part A) followed by ofatumumab with alemtuzumab for 12 to 24 weeks to maximum response (Part B). The trial therapy is designed to prepare eligible patients for reduced-intensity allogeneic stem cell transplant (SCT), and for those who are not transplant candidates, the trial includes a maintenance phase.

Primary Objective:

  • Determine the overall response rate (ORR) at the conclusion of 2-part induction therapy with ofatumumab-HDMP (Part A) followed by ofatumumab-alemtuzumab (Part B) in 2 cohorts of participants with 17p deletion: previously untreated or relapsed/refractory

Secondary Objectives:

  • Determine the complete response (CR) rate, rate of objective response by disease compartment (nodes/spleen, cytopenias/bone marrow), rate of minimal residual disease (MRD) negativity by 4-color flow cytometry, progression-free survival (PFS), and overall survival (OS) for induction therapy with ofatumumab-HDMP followed by ofatumumab-alemtuzumab in each cohort

  • Determine the ORR, CR rate, rate of objective response by disease compartment (nodes/spleen, cytopenias/bone marrow), and rate of MRD negativity at the conclusion of ofatumumab-HDMP; and at earlier interim analysis after 2 cycles of ofatumumab-HDMP

  • Determine the number of participants eligible to stop ofatumumab-HDMP after 2 cycles, and the number who complete 2 versus 4 cycles

  • Determine the improvement in ORR, CR rate, and the rate at which MRD negativity is achieved in bone marrow with ofatumumab-alemtuzumab, following initial HDMP-ofatumumab

  • Determine the improvement in ORR, CR rate, and rate of MRD negativity, and the rate of detectable recurrence of MRD or frank relapse, during maintenance ofatumumab-alemtuzumab in those participants not eligible for or willing to undergo allogeneic SCT

  • Determine the rate at which transplant-eligible participants are able (and willing) to proceed to allogeneic SCT for consolidation of remission

  • Assess the safety of ofatumumab-HDMP followed by ofatumumab-alemtuzumab in each cohort, and the safety of ofatumumab-alemtuzumab consolidation

Contact: Jennifer R. Brown, MD, PhD • 617-632-4564 • jennifer_brown@dfci.harvard.edu

ClinicalTrials.gov Identifier: NCT01465334

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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