Development of new cancer drugs is at the forefront of cancer research, and is a vital factor in the successful treatment of cancer patients. Helping to create the most optimized and innovative clinical research model for moving new agents from the laboratory directly to the patient in the safest, most expedient way possible is core to the vision of the Institute for Translational Oncology Research (ITOR) of Greenville Health System (GHS).
ITOR CRU Development Background
The ITOR Clinical Research Unit (CRU), which opened in August 2004 offers early phase treatments for cancer patients. The unit's proven commitment to effectively testing cancer drugs has established a reputation necessary to bring phase I research - the first stage of clinical pharmaceutical testing - to Greenville and the surrounding Upstate Region of South Carolina.
Traditionally, access to this level of clinical research was available only through a few select centers in the country, and patients living in the Upstate SC region would have to travel or move with their families to distant locations, disrupting their lifestyle during a critical time. The initial idea which led to the formation of the ITOR CRU was to have a dedicated, community- based phase I oncology drug development unit with the ability to move agents from the laboratory to the patient in the safest, most expedient manner - and allow patients in the Western Carolinas and Northeast Georgia to have access to those agents close to home. The ITOR CRU is uniquely designed with specialized equipment and staff to handle the demands of early phase development for cancer drugs.
The ITOR CRU Today
The ITOR Clinical Research Unit typically has more than 20 clinical trials open to patient enrollment at any given time. The ITOR CRU conducts first-in-human trials, which are exploratory studies to determine if drugs will behave as expected in humans. These early phase trials have brought new drugs with novel mechanisms of action to the Upstate SC Region much sooner than they would have otherwise been available. The ITOR CRU, South Carolina's first unit to obtain Bio- Safety II accreditation for viral vector and gene transfer studies, was the first site outside of Arizona to join the molecular profiling collaboration of the national Tissue Banking and Analysis Center. Currently, the ITOR CRU is the only facility in the state performing first in human oncology drug trials, and gene- based therapy using live viral vectors as a treatment for cancer.
Additionally, the Oncology Research Institute at the Greenville Health System (now known as the Clemson University Biomedical Institute) in conjunction with the ITOR CRU, has a track record in designing innovative, targeted therapies including a potential breakthrough agent for breast and ovarian cancer. This novel therapy will debut in the ITOR CRU in the near future through a phase I clinical trial. ITOR of GHS' continued collaboration with basic science investigators in the CU Biomedical Institute exemplifies the ability to advance cancer research from bench to bedside.
This degree of sophistication in research and development coupled with the unique structure in which ITOR's Clinical Research Unit has been established has been recognized on a national level. The panel advised the President and Congress on the national state of oncology care, focusing on new models for conducting cancer research. The ITOR CRU was held up as an example of a new and visionary way to conduct clinical research on new cancer drugs in a more cost efficient, patient friendly, and streamlined approach.
As the Clinical Research Unit evolved, Drs. Larry Gluck recruited Jeff Edenfield, MD and Suzanne Fanning, DO to the ITOR Team to broaden the opportunities for research. Additional oncologists of Cancer Centers of the Carolinas will be integrated as the phase I trials expand to optimize efficiency of referral and patient cancer care.
ITOR Regulatory Oversight:
The Greenville Health System which ITOR is part of currently has three active Institutional Review Committees (IRC) as follows:
- IRC(A) - General Research
- IRC(B) - Pediatrics and Women's
- IRCOR - Institutional Review Committee for Oncology Research
The IRCs meet monthly and are currently providing oversight for over 530 active clinical trials.
ITOR CRU Staff Training:
In accordance with Code of Federal Regulations Title 49: Transportation, all staff maintain Collaborative Institutional Training Initiative (CITI) and Good Clinical Practices (GCP) training. In addition, all staff involved in specimen processing/shipping maintain International Air Transport Association (IATA) training.
ITOR CRU Laboratory & Pharmacy Equipment:
The ITOR CRU is equipped with the necessary laboratory equipment for processing pharmacokinetics and other study specific testing. The pharmacy is equipped with a USP 797 Clean Room for IV admixture. In addition, the unit houses an isolated admixture room and glove box for viral vectors and gene transfer therapy.
The ITOR Clinical Research Unit Capabilities Include the following:
- Routine hours of operation 8am to 5pm Monday through Friday with a flexible staff schedule to handle after hours / weekend PKs or other assessments
- 9 outpatient treatment chairs
- Ability to admit a patient overnight with 4 dedicated research beds
- 1 isolation treatment room; 3 exam rooms
- Crash cart located within the infusion room with access to the Greenville Health System's rapid response and code team
ITOR CRU Governance:
A Protocol Review and Oversight Committee meets monthly with medical and radiation oncologists, surgeons, APRNs, pathologists & radiologists, pharmacists, and research nurses in attendance. The committee reviews all new studies to ensure scientific merit and the ability to meet enrollment expectations. The Committee also reviews protocol deviations, pertinent amendments and adverse events. In addition, the ITOR CRU holds a weekly staff meeting to review protocol deviations, pertinent amendments and adverse events.
ITOR CRU Experience with Novel Agents:
The opportunity for clinical trials ranges from new delivery techniques through live viral gene therapies, to autologous tumor vaccines (some of which are being developed locally in Greenville), and drugs employing new mechanisms of actions - called "designer drugs" - for tumor specificity.
Examples of agents administered in the ITOR CRU:
Monoclonal Antibodies Targeting:
- CD33
- CD40
- Prostate stem cell antigen
- IGFR
- Program death receptor - 1
- VEGFR - 2
- CTLA - 4
- EGFR
- TRAIL- 2
Compounds that inhibit:
- XIAP
- Scatter factor from binding c- met
- Eg5 protein
- PI3K pathway
- Multi- tyrosine kinases
- Thioredoxin- 1
- CDK
- Polo- like kinase
Vaccines:
- Antigenic vaccine in NSCLC
- Whole cell vaccine for prostate cancer
- Dendritic vaccine for RCC and melanoma
Viruses:
- Adenovirus that targets Rb pathway defective cancer cells
- Adenovirus that is transfected with the TNF gene
- Vaccina virus
- Seneca Valley Virus
Why Choose the ITOR Clinical Research Unit?
The unit has established a reputation for providing high quality clinical trials through its expert team with proven capabilities.
- Demonstrated Track Record / Performance
- Direct support from the Greenville Health System
- Cancer Centers of the Carolinas - Major Patient Referral Source
- Biorepository Services - ability to handle tissue
- Successful FDA Audits - navelbine, herceptin, dendritoma vaccine (no 483 issued)
- Collaborative relationship with local IRB
- Ability to initiate a trial within 8 weeks of receipt (Simultaneous contract/budgeting and regulatory process)
