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Phase I/Investigational Therapeutics Program

Phase I Team

The Phase I/Developmental Therapeutics Program at the Rutgers Cancer Institute of New Jersey is a multidisciplinary scientific group designed to develop new methods for the treatment of cancer. The program includes a team of medical oncologists, nurses, research scientists, data coordinators, and social workers who have extensive experience in providing novel therapeutic strategies. The program conducts trials of novel targeted therapy approaches, including genomics-directed protocols, and novel immuno-oncology approaches, as well as first in human trials of novel compounds. Clinical trial offerings are diverse and include partnerships with academia, industry, and government. 

Through this program, patients, and physicians have access to the newest and the most promising cancer treatments supported by the National Cancer Institute, pharmaceutical companies and the Rutgers Cancer Institute of New Jersey. Patients with a variety of cancers are typically eligible to receive these new treatment options. Patients may have received multiple types of prior therapies or even occasionally, are referred for treatment prior to receiving any anticancer therapies. The Phase I team meets weekly to discuss current and pending clinical trials, and reviews all patients on Phase I clinical trials.

What is a Phase I Clinical Trial?

Clinical trials occur in multiple phases. After a promising drug or compound is developed in the laboratory, the first step of moving information from ‘bench to bedside’ is an early phase clinical study, such as a Phase I trial. The major focus on a Phase I trial is to assess the safety of new agents and establish the most effective method of administration. Treatment is typically administered in small groups of patients in increasing doses in order to determine the maximum dose that does not cause significant side effects. Often times, patients are asked to give tissue or blood samples to help researchers investigate the mechanism of action and how the drug is absorbed in the body. Phase I clinical trials are a viable option for patients that have not had success on standard therapies and have exhausted other available options. Since little is known about the investigational agent, tumor shrinkage or disease stabilization is not a guarantee but still an important goal.

Clinical trials usually have an element of risk that is different from standard therapy, and phase I clinical trials are no exception. New agents may have unpredictable side effects, and rates of cure and survival are often not known in drugs being tested in clinical studies. However, clinical trials are often offered to patients when the standard therapies that are available work very poorly, or are shown to be ineffective. In these situations, a clinical trial can potentially provide access to a promising agent that is not otherwise available to patients. Clinical trials are also important to others living with cancer, as the questions answered by these trials often move the field forward and optimize treatment approaches.

 

Clinical Trials:

Staff of this Program:

Janice Mehnert, MD, Director, Phase I and Investigational Therapeutics Program, and Medical Oncologist
Nancy Chan, MD, Medical Oncologist
Eugenia Girda, MD, FACOG, Gynecologic Oncologist
Roman Groisberg, MD, Medical Oncologist
Jyoti Malhotra, MD, MPH, Medical Oncologist
Kristen Spencer, DO, MPH, Medical Oncologist
Mark Coogan, Advanced Practice Nurse
Laura Sullivan, RN, BSN, Nurse Navigator
Alyssa Iwano, RN, BSN, OCN, Research Nurse Clinician
Debbie Pomponio, RN, BSN, Research Nurse Clinician
Melissa Frankel, RN, BSN Research Nurse Clinician
Demmie Aguilar, Research Coordinator
Rebecca St. Fort, Clinical Research Coordinator
Aparna Kareddula, PhD, Clinical Research Coordinator
Daniella Portal, BS, Research Study Assistant and Data Manager
Joanne Onyschak, CCRP, Phase I Program Development Analyst

 

 

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