The Developmental Therapeutics Program at the Abramson Cancer Center is dedicated to the study of promising new drugs, or combination of drugs in treating cancer. It is through these studies that innovative drugs, discovered in the laboratory, are brought to the patient. The hope is that these new drugs will broaden the treatment options available to cancer patients while improving care and quality of life.
Over the last decade, many people with cancer have witnessed the success of studies that have helped improve and increase treatment options. It is only through research that we can offer the next patients a better outlook for cure.
About Clinical Trials
The Developmental Therapeutics Program tests these new drugs by conducting Phase I and II clinical trials. Clinical trials are studies to determine the effectiveness of new ways to prevent, detect and treat cancer. The purpose of each clinical trial is to answer a specific question.
Phase I trials are the first step in testing a new treatment in humans. The major intent of Phase I studies is to establish how a particular treatment will act and the safety limits of the treatment. In these studies, researchers look for the best way to give a new treatment -- such as by mouth, or injection -- and how frequently it should be given. They also try to find out the best dose that can be given safely.
In order to do this; the treatment is given to small groups of patients in increasing dosages, and often by different routes. Patients are carefully watched for harmful side effects. Usually one group receives one dosage; another receives a different dosage. This process continues in order to find out the highest dose that does not cause harmful side effects. At the end of Phase I trials, it is generally known which doses are safe and how best to deliver the treatment.
Because less is known about the possible risks and benefits in Phase I trials, these studies usually include only a small number of patients who would not be helped by other known treatments. Tumor shrinkage or stabilization is an important goal of therapy but usually occurs only in a small number of patients. In some cases the treatment may be administered at a dosage that is too low to be effective, or the treatment may be ineffective at any dose.
Phase II trials continue to test the safety of the drug and begin to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer. These trials work on learning whether the new treatment works--such as: does it shrink a tumor? As in Phase I, only a small number of people take part because of the risks and unknowns involved.
In order for Phase II trials to determine which particular cancer responds to a treatment, studies are done in a group of patients with the same type of cancer. To participate in Phase II trials, people with cancer usually must have what is called "measurable disease." This means that there is at least one tumor present that can be seen on physical examination or a study, such as an x-ray, CT or MRI scan.
In Phase II trials the tumor size is measured and tracked to see the response to treatment:
In clinical trials, both research and patient well being are important. Research with people is carried out according to strict scientific and ethical principles. These include:
People take part in cancer clinical trials for many reasons. Certainly, they hope to benefit personally from the new approach under study, since clinical trials also give patients access to the latest advances available in the nation. Others participate as a way to prevent or treat cancer for future generations, including their own family and the community at large.
Each trial has specific eligibility requirements. Not everyone is an appropriate candidate for a Phase I or II study. The most important thing is whether the trial is the best treatment option at the time. If better treatment options exist, or the risk of side effects is too high, other approaches should be pursued.
To find out if you are eligible for a particular Phase I or II trial, please consult the Cancer Center's clinical trials matching service on OncoLink.
Generally, you must meet the following criteria to be eligible:
Patients who may be under consideration for hospice and other forms of terminal care are not candidates for a phase I or II trial.
If you are eligible for a Phase I or II trial you will meet with a physician on the research team. The physician you see varies, depending on your type of cancer. During this visit, you will receive information on the different options available to you and specific recommendations about which trial may be appropriate for you.
If the physician recommends enrolling in a trial, the next step is to go home and think about what you have discussed. You will have received a consent form during your visit. You should read this in detail at home. After taking time to think about all the information you've been given, you will have the chance to meet with a nurse specialist who will provide additional information and discuss any concerns and questions you may have.
In some cases, enrolling in a trial is not the best approach. In such cases the physician will recommend that you not take part in the trial.
Penn's Developmental Therapeutics Program is a highly interactive group of investigators from multiple clinical and basic science departments. Program members are responsible for the development and conduct of trials in a particular field with an emphasis on innovative treatment approaches.
The experimental therapeutics research project team evaluates novel therapies in well-designed, hypothesis-driven, Phase I and Phase II studies for a range of cancers. The Developmental Therapeutics Program is pursuing studies of novel and targeted agents with endpoints that include clinical effects, pharmacokinetics, MRI studies of blood flow, pharmacogenetics, gene expression, and pharmacogenomics. With the help of a recently awarded Phase II contract, studies are underway in head and neck cancer, colon cancer, melanoma, non-small cell lung cancer and an array of targeted therapies. Among the agents under investigation in Phase I and II trials are epothilones, novel taxanes, novel platinum compounds, anti-vascular and anti-angiogenic agents, kinase inhibitors, and PPAR-gamma agonists. Pharmacodynamic studies of novel agents round out the developmental focus of the group.
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