Developmental Therapeutics Clinic

What Is the Developmental Therapeutics Clinic?
What Is a Phase I Clinical Trial?
Am I Eligible for a Phase I Clinical Trial?
Who Do I Contact for More Information?
What Happens Once My Developmental Therapeutics Clinic New Patient Appointment Is Made?
What Will My Developmental Therapeutics Clinic New Patient Appointment Be Like?
What Is it Like to Participate in a Phase I Clinical Trial?

What Is the Developmental Therapeutics Clinic?

The Developmental Therapeutics Clinic conducts Phase I clinical trials, and is comprised of a team of medical oncology attending physicians, fellows, advanced practice/research nurses, and data managers, who work together to develop new cancer treatments. These new cancer treatments are often first-in-human studies, having already been shown effective in laboratory and animal studies. The three main goals of the Developmental Therapeutics Program are to evaluate these new drugs to determine: the best dose strength and schedule of administration, how a patient's body metabolizes the drug, and study-drug related side effects.

What Is a Phase I Clinical Trial?

A clinical trial is a study conducted with cancer patients to evaluate new treatments for cancer. Before these studies take place with cancer patients, extensively research is done in the laboratory and on animal models. If a drug being studied is found to shrink tumors in these pre-clinical studies, they are then evaluated further in clinical trials. The potential benefit and toxicity of the drug under study can be estimated by the pre-clinical studies. However, these studies cannot predict exactly what will happen with actual patients.

The Phase I clinical trial allows us to evaluate promising new drugs in patients with advanced cancer. The purpose of Phase I trials is to define the best dose of the new drug, the side effects of the new drug and, potentially, the types of cancer that this new drug may work in. These drugs are often first-in-human studies and represent a critical step in drug development, from the laboratory to the clinic. As most standard cancer treatments were first studied in clinical trials, these studies provide an opportunity for the patient to receive a new type of treatment if his/her cancer does not respond to standard treatment or if there is no standard treatment available.

Am I Eligible for a Phase I Clinical Trial?

Typically, patients need to have reasonably normal kidney, liver and bone marrow function to be eligible for our clinical trials. Also, patients cannot be too ill from their cancer. In other words, they cannot spend more than 50% of the day lying down or resting, need to be able to perform their normal daily activities, and cannot have lost a significant amount of weight recently.

Each of our studies has additional particular eligibility requirements, however the general eligibility criteria include but are not limited to the following:

Histologically proven incurable malignancy
No effective alternative therapy available
18 years of age or older
Ambulatory with an ECOG performance status of 0-2
Clinically adequate hematologic, hepatic, renal, and metabolic function
No recent therapy or surgery within 3-4 weeks of study entry

Who Do I Contact for More Information?

Call the Lombardi CancerLine at (202) 444-4000 for more information. An oncology-certified registered nurse will obtain your cancer history to guide you toward the most appropriate clinical trials ongoing within Lombardi.

The nurse will then offer to refer your case to the appropriate physician or advanced practice/research nurse, who under most circumstances will contact you within two weekdays. The purpose of this contact is to provide more detailed information about the clinical trials, perform a brief telephone pre-screen for general eligibility criteria, and help you obtain a new clinic appointment for a formal medical oncology evaluation within the correct clinic.

What Happens Once My Developmental Therapeutics Clinic New Patient Appointment Is Made?

Once a Developmental Therapeutics Clinic new patient appointment is made, a New Patient Information Packet will be mailed. This packet will include:

a map with directions to the Lombardi Comprehensive Cancer Center
a medical history questionnaire to be completed by the patient and brought to the appointment
a letter from the Developmental Therapeutics Team requesting the patient also bring the scan films and written radiology reports from his/her two most recent scan dates, and his/her Paraffin embedded tumor tissue block and written pathology report which he/she will need to obtain from the Pathology department of the facility where the most recent tumor biopsy or surgical resection was performed

What Will My Developmental Therapeutics Clinic New Patient Appointment Be Like?

The initial Developmental Therapeutics Clinic appointment will last approximately two hours. During this time, the patient will meet several members of the team, the medical records (faxed to us from the primary oncologist) will be reviewed, the scan films will be placed on the viewing box and read, and a physical examination will be completed. The patient's case will then be discussed by the team to determine the most appropriate treatment recommendations, and these recommendations will then be presented and discussed with the patient.

If the treatment recommendations include a particular Phase I trial, then detailed verbal and written information about that study will be provided along with contact phone numbers. The patient will be asked to keep us informed about his/her treatment decisions, and encouraged to contact us with further questions or concerns. Additionally, the patient's primary oncologist will receive communication regarding our treatment recommendations.

What Is it Like to Participate in a Phase I Clinical Trial?

In general, patients participating in a Phase I clinical trial can expect to be seen here at Lombardi on a weekly basis. This frequency of visits helps the Developmental Therapeutics team closely monitor the patient for safety and side effects, as well as dispense the study drug to the patient. Additionally, frequent blood and urine testing helps us to measure and develop a better understanding of how the patient's body metabolizes the study drug. Some Phase I trials do require occasional overnight hospital stays, and/or occasional extended-day outpatient visits.

Some of our Phase I trial medications are orally administered (by mouth), though most are intravenously administered via central venous catheter. Some of these intravenous study drugs are given alone, while others are given in combination with a standard chemotherapy. Others are given by continuous around-the-clock infusion for which the patient carries a purse-sized portable infusion pump on the days of therapy.

For the most part, patients may continue to take their usual daily medications, and we will readily prescribe appropriate medications to help control unwanted side effects whenever possible. At times, the investigational drug (and/or the standard chemotherapy if on a combination study) may need to be held or given at a reduced dose in order to lessen unacceptable side-effects.

In general, we will monitor for cancer response to investigational therapy every six to eight weeks by looking at tumor marker levels in the blood, and/or CAT scan measurements of tumors. As long as the investigational drug seems to be providing the patient some benefit, and he/she is tolerating it reasonably well, we will likely recommend continuation on that therapy. If/when the cancer does not appear to be responding to the study drug, we will need to discontinue that particular therapy, but will provide further recommendations regarding treatment options.

A patient always has the option to withdraw consent and discontinue participation in the clinical trial if he/she desires. Lombardi Comprehensive Cancer Center's medical oncology staff will always be available to the patient 24 hours a day/7 days a week for patient questions and concerns.