What are Phase I cancer clinical trials?

Phase I trials are part of the beginning steps required to develop new cancer drugs for patients. The experimental drugs have already been tested in the laboratory and in animals, but this is the first time they have been tried in humans. Phase I trials often involve small numbers of patients (a few dozen). The focus is on finding the maximum effective dose that can be given without unacceptable side effects. Usually the doses given to the first participants are smaller than the doses given to later participants, and doses typically are increased over time for newer participants as safety data accumulates. Because Phase I trials come early in the drug development process, the trial may consist of participants with a wide variety of cancer types. Phase I trials are mostly offered at academic medical centers like BIDMC, which is a founding member of the Dana-Farber/Harvard Cancer Center.

Who can participate in Phase I cancer clinical trials?

Clinical studies have eligibility criteria that are part of the research plan. Some seek participants with specific cancer types while others are not cancer-type specific. Most often Phase I cancer trials require participants to have advanced cancer that cannot be removed by surgery or completely treated by radiation therapy. Your doctor will make a recommendation based on the study plan and your situation.

How do I find out what trials are available, and which might be appropriate for me?

You can search clinical trials available through the BIDMC Cancer Center at bidmc.org/cancerclinicaltrials. Your doctor will discuss with you whether considering participation in a trial is appropriate in your situation.

Does my treatment need to fail for me to qualify for a Phase I trial?

Some participants enroll in Phase I trials after other therapies have been unsuccessful or have run their course. Others choose to participate to attempt to enhance standard treatment with a new combination treatment option or because they are seeking a different treatment option.

How likely am I to benefit from a Phase I study?

While Phase I studies do not use placebos, their primary purpose is to evaluate drug safety and dosages. The drug’s effectiveness and its value in comparison with existing therapies are typically the focus of Phase II and Phase III trials, respectively. At any given time, in addition to Phase I studies, there may also be Phase II and Phase III studies taking place at BIDMC.

It is important to carefully review the potential risks and benefits of Phase I trials. Phase I trials can achieve benefits for some patients.

Are there other benefits?

Phase I trials, like Phase II and III trials, can offer participants additional benefits. Many, if not all, treatment drugs and study-required tests are free to study participants. Successful clinical trials may improve the length and quality of life for study participants. Clinical trials provide an opportunity to take positive action by contributing to the understanding of a disease or condition and by furthering treatment options available to others. Patients in successful clinical trials are the first to get access to these cutting-edge treatments.

Can I still see my regular doctor?

Yes. Typically your regular doctor continues to provide your overall cancer care management. However, you will have the support of an additional team of experienced research doctors and research nurses who will coordinate with your regular doctor.