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 Perifosine With Temsirolimus for Recurrent Pediatric Solid Tumors

Principal Investigator: Ira Dunkel, MD

Condition: Pediatric solid tumors

Institution: Memorial Sloan-Kettering Cancer Center

The purpose of this study is to test the safety and effectiveness of perifosine in combination with temsirolimus in children with solid tumors. Neither drug is currently part of the standard treatment of solid tumors in children; however, there is now new insight that if given together, perifosine and temsirolimus may work to stop the growth of solid tumors and may also make them shrink. Four different dose schedules of perifosine with temsirolimus will be tested.

Primary Outcome Measures:

Maximum tolerated dose (MTD) of combination perifosine and temsirolimus in children with cancer

Secondary Outcome Measures:

  • Determine whether pharmacokinetic serum levels of both perifosine and temsirolimus correlate with toxicity

  • Record preliminary data on the efficacy of combination perifosine and temsirolimus

  • If previously resected tissue is available, determine whether molecular features predict response, including elevated PI3K/AKT/mTOR signaling, elevated RAS/MAPK signaling, and cell cycle markers.

Contacts: Ira Dunkel, MD • 212-639-2153

Stephen Gilheeney, MD • 212-639-3973

ClinicalTrials.gov Identifier: NCT01049841

A Phase I Study of Bortezomib (VELCADE) in Combination With Pralatrexate in Relapsed/Refractory Multiple Myeloma

Principal Investigator: Michaela Liedtke, MD

Condition: Multiple myeloma

Institution: Stanford University

This is an open-label phase I dose-escalation safety study of bortezomib in combination with pralatrexate in patients with previously treated multiple myeloma. In a standard 3 + 3 dose escalation trial design, escalating doses of pralatrexate in combination with bortezomib will be studied until the maximum tolerated dose is determined.

Primary Outcome Measures:

  • Determine maximum tolerated dose for the combination of pralatrexate with VELCADE in previously treated adult patients with multiple myeloma

Secondary Outcome Measures:

  • Clinical evidence of antitumor activity based on response rates

  • Time to progression assessed after each 4 week cycle (up to 4 cycles) and every 3 months for the first 2 years from protocol registration, every 6 months for years 3 to 5, and annually thereafter

  • Duration of response outcome assessed after each 4 week cycle (up to 4 cycles) and every 3 months for the first 2 years from protocol registration, every 6 months for years 3 to 5, and annually thereafter

  • Progression-free survival assessed after each 4 week cycle (up to 4 cycles) and every 3 months for the first 2 years from protocol registration, every 6 months for years 3 to 5, and annually thereafter

  • Overall survival assessed after each 4 week cycle (up to 4 cycles) and every 3 months for the first 2 years from protocol registration, every 6 months for years 3 to 5, and annually thereafter

Contact: Vani Jain • 650-725-5459

ClinicalTrials.gov Identifier: NCT01114282

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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