Center for Cancer Therapeutic Innovation Clinical Research and Trials

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Clinical Trials Questions?


Our Clinical Research

At the Center for Cancer Therapeutic Innovation (CCTI), we focus on innovative therapeutic approaches that include new drug evaluations, new combination approaches, and testing more established drugs in new settings where they may have benefit.

The focus of the Center is on clinical and translational research: clinicians in the Center partner with laboratory scientists and companies to evaluate how a drug or drug combination or other therapeutic combination might work in different settings — through studies in animal models, cell culture, patient samples, and patients.

These therapies can work through any type of mechanism and can include novel immunotherapies, targeted therapies, chemotherapies, therapies that affect tumor metabolism or cause protein modification/degradation or many other ways of killing cancer cells. These novel therapies may also combine more than one mechanism of action. Some of our trials include combinations with radiation or other local treatments or novel drugs that can be tracked in the body and imaged.

Our Clinical Trials

Clinical trial evaluations of new drugs in patients are conducted under very rigorous conditions to protect patients' safety. CCTI conducts both phase I and phase II trials using a dedicated research staff that includes:

  • Physicians with specific disease expertise and expertise in early drug development
  • Dedicated physician assistants/nurse practitioners
  • Research nurses
  • Research coordinators
  • Regulatory staff

All these experts work closely together to ensure that we conduct clinical research with the utmost consideration for a patient's safety and well-being, and with care to help navigate all of the different requirements for patients to participate in clinical trials.

Clinical Trials Q&A

What are clinical trials, and what is a phase I clinical trial?

Clinical trials of new cancer therapies go through various phases in the development of a new treatment.

First, there must be some evidence — from laboratory testing, animal testing, or other studies — that a new drug or drug combination might be effective against a particular type of cancer. This evidence might come from a drug company or from a doctor who is already working in research.

What happens in a phase I trial?

The goals of a phase I study are to:

  • Find out how to give a new therapy safely (how much of a new drug, how to combine with other therapies, what are the side effects at different doses or combination).
  • Get an initial understanding of the potential effectiveness of a therapy.

A phase I study often consists both of a dose-finding portion, where only a few patients are treated at a given time, and a dose-expansion portion, where the safety and efficacy of the therapy are further evaluated in specific cancer types/settings.

If there is evidence that a new therapy has some promise for treating cancer, it may be further studied in a phase II or phase III setting in a specific cancer type. The goals of a phase II study are to continue to gather additional information about the safety of the therapy, and to test whether or not the drug works against a specific kind of cancer. Phase III trials are much larger and will enroll hundreds, or even thousands, of people to compare the effectiveness of the new treatment with either a placebo or an existing treatment in a randomized study.

What happens in phase II "basket" trials (multi-malignancy)?

Because CCTI treats patients with all different types of cancers, this Center is also where we conduct phase II basket trials — trials of drugs that are being tested in several cancer types at the same time. These drugs may have been tested in phase I settings previously or are even already approved in a specific cancer type, but are now being tested in different settings where it is hoped they may also prove beneficial. These studies focus on evaluating efficacy (as well as safety) of an established dose in different specific cancer types/settings. You may be referred by your doctor for this type of trial if your tumor is found to carry a specific genetic alteration or express a specific protein that is found in more than one cancer type.

What can I expect?

When you first come to CCTI, you will meet with a physician with expertise in your specific cancer and a program nurse who will help you evaluate different options, including options other than clinical trials.

Once you decide to take part in a clinical trial, you will undergo assessments to evaluate whether you are eligible for the trial (screening procedures) which may include lab work, scans, tests of your heart rhythm, and sometimes extra tumor biopsies. The procedures that you follow during screening — as well as when you are treated on a trial — will depend on which the type of therapy you are taking. You may be given tablets to take at home, or you may need to come into the clinic regularly for an intravenous infusion (through a needle in your arm); you may have a combination of treatments that involve drugs and radiation or other types of therapy.

In most studies, you will need to come into the clinic on the first day and at regular intervals for blood tests and other procedures. Some will be quick visits (one to two hours); others may be much longer (10-12 hours).

We will explain the details of your particular clinical trial before you sign the consent form. You will be given a detailed calendar outlining all the required study visits.

Protecting Patients in Clinical Trials

One thing to keep in mind about participating in a clinical trial is that the experimental study drug may not help your cancer. Also, because it is a new treatment, you may experience side effects of the new therapy that have not yet been identified.

However, it is only by testing new therapies through clinical trials that new and effective cancer treatments can be developed for the future.

All research carried out at Dana-Farber must first be approved by the Institutional Review Board (IRB). The IRB is a group of experts and patient representatives who examine the scientific evidence for testing a new drug and, most importantly, look at the design of the study to make sure it is well planned and as safe as possible for participants.

Research studies can enroll participants only once this approval has been granted. The IRB continues to monitor studies as they progress to check that the trials are being carried out safely and correctly.

Learn more about clinical trials at Dana-Farber.