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.

Ofatumumab in Combination With Chemotherapy: Hyper-Fractionated Cyclophosphamide, Doxorubicin, Vincristine, and Dexamethasone Alternating With Ofatumumab High-Dose Cytarabine and Methotrexate for Patients With Newly Diagnosed Mantle Cell Lymphoma

Principal Investigator: Francisco Hernandez-Ilizaliturri, MD

Conditions: Mantle cell lymphoma

Institution: Roswell Park Cancer Institute

This phase II trial examines how well ofatumumab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and dexamethasone (Hyper-CVAD) alternating with ofatumumab in combination with high dose cytarabine and methotrexate (HD-MA) works in patients with newly diagnosed mantle cell lymphoma (MCL). Monoclonal antibodies, such as ofatumumab, can block cancer growth and spread in different ways. In addition, monoclonal antibodies can assist the immune system in eliminating cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, dexamethasone, cytarabine, and methotrexate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving ofatumumab together with alternating regimens of combination chemotherapy may eliminate more cancer cells.

A maximum of 53 patients at 2 sites (Roswell Park Cancer Institute and Vanderbilt-Ingram Cancer Center) will be enrolled. Accrual is expected to take up to 2 years. It is expected that patients will be receiving treatment on this study for approximately 6 months, after which, if eligible, patients will receive an autologous stem cell transplant (ASCT).

Primary Objective:

  • Determine the overall response rate (ORR), and in particular, the complete remission rate (CRR) in previously untreated MCL treated with ofatumumab in combination with aggressive chemo-immunotherapy

Secondary Objectives:

  • Determine the high-sensitivity flow cytometry CRR in previously untreated MCL treated with ofatumumab in combination with aggressive chemoimmunotherapy ± high dose chemotherapy (HDC) and ASCT

  • Determine the time-to-progression (TTP), PFS, and OS of patients with previously untreated MCL treated with ofatumumab and aggressive chemoimmunotherapy ± HDC-ASCT

  • Determine the toxicity profiles of ofatumumab in combination with high dose cytarabine chemoimmunotherapy ± HDC-ASCT

  • Correlate minimal residual disease (MRD) at different time intervals with TTP, PFS, and OS

  • Correlate surface CD20 levels, Ki67, and additional cytogenetic abnormalities in pretreatment tumor biopsies with respect to ORR, CRR, TTP, PFS, or OS

  • Determine the relationship between proliferation signature and clinical outcome using quantitative real-time reverse transcriptase polymerase chain reaction

  • Determine changes in surface CD20 levels, Ki67, or gain of additional cytogenetic abnormalities in relapsed/refractory tumor specimens

  • Correlate serum C3, C4, and CH50 levels measured at baseline and at the end of first ofatumumab infusion with ORR, CRR, MRD, TTP, PFS, and OS

  • Evaluate the ability of the induction and consolidation therapy to obtain 70% of patients to reach ASCT

  • Evaluate the tolerability and CD34+ cell yield following therapy with patient and Hyper-CVAD/HD-MA

  • Compare differences in response rate in patients with MCL treated with ofatumumab + Hyper-CVAD/HD-MA according to Cheson and modified Cheson criteria

Contact: Roswell Park Cancer Institute • 877-275-7724 • AskRPCI@roswellpark.org

ClinicalTrials.gov Identifier: NCT01527149

Phase II Study Evaluating the Role of Pazopanib in Angiosarcoma

Principal Investigator: Margaret von Mehren, MD

Conditions: Angiosarcoma

Institution: Fox Chase Cancer Center

Pazopanib has shown encouraging activity in a previous phase II trial in certain sarcoma subtypes. In the EORTC phase II trial of pazopanib, the progression-free rate at 12 weeks exceeded 40% for patients with leiomyosarcomas, synovial cell sarcomas, and other eligible sarcomas, but not liposarcomas. In the group of other sarcomas, 5 were described as vascular sarcomas.

The investigators hypothesize that pazopanib will have therapeutic activity in angiosarcoma because they are derived from endothelial cells, and pazopanib is an antiangiogenic agent. In addition, agents with antiangiogenic properties have shown single-agent activity in this disease. Sorafenib has been shown to have a 14% response rate in angiosarcomas in previously treated patients in the phase II setting. Bevacizumab has demonstrated a 12% response rate. Given the limited data on the activity of pazopanib in angiosarcomas, the investigators propose to evaluate its activity in patients with angiosarcoma.

Primary Objective:

  • Determine the response rate, defined as complete response and partial response in patients with an angiosarcoma treated with pazopanib

Secondary Objectives:

  • Determine the progression-free survival (PFS) at 3 months

  • Assess overall survival (OS) of patients treated with pazopanib

  • Gather more safety data for pazopanib in this patient population

  • Explore the ability of PET with RGD-5 and FDG imaging to assess response

Contact: Margaret von Mehren, MD • 215-728-2460 • margaret.vonmehren@fccc.edu Beth Adair-Halenda, CCRP • 215-214-3704 • beth.adaire@fccc.edu

ClinicalTrials.gov Identifier: NCT01462630

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 NCCN.org/clinical_trials/clinicians.asp.

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