When Cancer Recurs, Phase I Clinical Trials Can Expand Treatment Options


Most cancer patients with refractory disease have limited choices on the menu of standard treatments, but phase I clinical trials can expand those options and offer hope. Roswell Park Comprehensive Cancer Center is home to the largest phase I oncology clinical trials program in New York State, enrolling patients on dozens of different trials at any given time. Patients enrolled in clinical trials at Roswell Park were among the first to benefit from such treatments as the breast cancer drug Herceptin and the leukemia drug Gleevec, both of which proved more effective than the standard of care at the time.

Here Alex A. Adjei, MD, PhD, FACP, Chair of the Department of Medicine and Senior Vice President of Clinical Research at Roswell Park, answers questions about the program:

Q: What’s the overall focus of Roswell Park’s phase I program?

A: We concentrate on innovative, frontline cancer treatments — including promising new immunotherapies and targeted agents — that have the potential to treat the disease effectively while maintaining quality of life. The program offers clinical research studies for cancers for which there are very few available treatments, and provides some therapies that are available nowhere else.

Q: How have phase I oncology clinical trials changed in recent years?

A: One major step forward is that most agents tested previously in phase I studies were disease-site-specific — designed to treat only one type of tumor. Today they’re developed to treat virtually any type of solid tumor, so most trials are open to a broader range of patients.

Q: Does Roswell Park offer phase I clinical trials of cancer vaccines?

A: Yes, cancer vaccines are among the immunotherapies available through our phase I program. Recently we conducted a phase I trial of SurVaxM, a brain cancer vaccine developed by our own investigators. Based on the encouraging results of the first phase I trial, the FDA has authorized an extension to enable some of the participants to continue receiving treatments for the next two years.

We also offer phase I trials of the cancer vaccine NYESO-1, also developed by a Roswell Park researcher, which has shown efficacy against advanced ovarian cancers and is now being evaluated in phase I clinical trials of other types of solid tumors.

Q: Where are patients treated when they enroll in a clinical trial at Roswell Park?

A: Our clinical trial participants receive care in Roswell Park’s Clinical Research Center (CRC), which is equipped for frequent and complex patient monitoring and frequent sample collection. The CRC staff specialize in initiating and managing phase I oncology clinical trials. The center is also served by a dedicated Investigational Drug Service located in the treatment area, so pharmacists are available to answer questions for patients, families, staff, and colleagues.

Roswell Park’s CRC is one of few oncology-specific clinical research centers in the nation and plays a key role in helping us attract important clinical trials sponsored by pharmaceutical companies.

Q: How can I find clinical trials at Roswell Park that might be appropriate for my patients?

A: Visit www.roswellpark.org/clinical-trials, or call our clinical research administrator at 716-845-3165.