ABCDE test n.
General guidelines used to assess a suspicious mole for melanoma. Factors evaluated include asymmetry, irregular border, uneven color, change in diameter and elevation of the mole.

adjuvant therapy n. (AD-juh-vent)
Treatment given after the primary therapy to increase the chances of a cure. Adjuvant therapy for cancer may include chemotherapy, radiation therapy or hormone therapy.

anesthetic n.
Any drug that causes unconsciousness or a loss of general sensation

biopsy n. (BY-op-see)
Removal of a sample of tissue from a living person for laboratory examination

chemotherapy n.
Use of chemical agents in the treatment or control of disease or mental illness

clinical trial n.
Study designed to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research or research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work.

Once researchers test new therapies or procedures in the laboratory and get promising results, they begin planning clinical trials. New therapies are tested on people only after laboratory and animal studies show promising results.

Learn more about a Phase III clinical trial of an experimental cancer vaccine for metastatic melanoma.

computed tomography (CT) scan n.
An X-ray procedure in which the X-ray beam moves around the body, taking pictures from different angles. These images are combined by a computer to produce a detailed cross-sectional picture of the inside of the body.

control n.
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while another group (the control) is given either a standard treatment for the illness or a placebo.

cytokine n. (SIE-toh-KINE)
Any of a class of immunoregulatory substances that are secreted by cells of the immune system. Although cytokines are not really different from hormones, the term tends to be used to describe substances such as interleukins, lymphokines and several related signaling molecules such as tumor necrosis factor and interferons.

dermis n.
Thick sensitive layer of skin or connective tissue immediately beneath the skin’s epidermis (the outermost layer) that contains blood, lymph vessels, sweat glands and nerve endings

DTIC-DOME^® (dacarbazine) n. (da-CAR-ba-zeen)
Type of chemotherapy given as a treatment for some types of cancer, especially melanomas

epidermis n. (eh-peh-DER-mis)
Thin outermost layer of skin. It is made up of several layers and covers and protects the underlying dermis layer of connective tissue.

exclusion criteria n.
When determining a patient’s eligibility for a clinical trial, exclusion criteria describe those factors that, if present, would disallow a candidate’s participation in the study. Common exclusion criteria include other serious diseases, pregnancy and compromised immunity.

five-year survival rate n.
Describes the percentage of patients who live at least five years after their cancer is diagnosed. Five-year relative survival rates exclude patients dying of other diseases, which means that anyone who died of another cause, such as heart disease, is not counted.

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immune system n.
The body system, made up of many organs and cells, that defends the body against infection, disease and foreign substances. The term describes the interacting combination of all the body’s ways of recognizing cells, tissues, objects and organisms that are not part of itself, and initiating the immune response to fight them

immunotherapy n.
Treatment of disease by stimulating the immune system. Also called immune therapy, biological therapy, or biological response modifier therapy.

Learn more about an experimental immunotherapy for metastatic melanoma.

incisional or excisional biopsy n.
Type of biopsy in which a surgeon cuts through the skin to remove the entire mass (excisional biopsy) or a small part of a large tumor (incisional biopsy).

inclusion criteria n.
When determining a patient’s eligibility for a clinical trial, inclusion criteria describe those factors that must be present in order for a candidate to participate in the study.

informed consent n.
A process in which a person learns key facts about a clinical trial or medical procedure, including potential risks and benefits, before deciding whether or not to participate in a study. Informed consent continues throughout the trial.

Institutional Review Board (IRB) n.
Group of scientists, doctors, clergy and consumers at each health care facility that participates in a clinical trial. IRBs are designed to protect study participants. They review and must approve the action plan for every clinical trial. They check to see that the trial is well designed, does not involve undue risks, and includes safeguards for patients.

interferon n. (in-ter-FEER-on)
Any of a family of glycoproteins derived from human cells that normally has a role in fighting viral infections by preventing virus multiplication in cells

interleukin n. (in-ter-LOO-kin)
Any of several secreted regulatory proteins that are members of the family of cytokines (immune system chemicals) that affect functions of specific cell types. Interleukins are produced by immune system cells such as lymphocytes and macrophages and monocytes, and modulate inflammation and immunity by regulating growth, mobility and differentiation of lymphoid and other cells.

intravenous (IV) adj.
Used in administering fluids or medicines into the veins

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lymph node n.
Any of the small, bean-shaped organs located throughout the lymphatic system. The lymph nodes contain the immune system cells lymphocytes, which can trap cancer cells or bacteria that are traveling through the body in lymph.

lymph system n.
Network of vessels that transport fluid, fats, proteins and lymphocytes to the bloodstream as lymph, and remove microorganisms and other debris from tissues. Also called lymphatic system.

malignant adj.
Tending to infiltrate, metastasize and become progressively worse

melanin n. (MEL-uh-nin)
Dark brown or black pigment that is naturally present to varying degrees in the skin, hair, eyes, fur or feathers of people and animals, as well as in plants

melanocyte n. (meh-LAN-o-site)
Type of cell in the skin that produces the pigment melanin that gives skin its natural color. Melanoma skin cancer occurs in the melanocytes.

metastasis n. (meh-TA-sta-sis)
Transfer of disease from one organ or part to another not directly connected with it. It may be due either to the transfer of pathogenic microorganisms or to transfer of cells, as in malignant tumors. The capacity to metastasize is a characteristic of all malignant tumors.

mole n.
Small, dark, sometimes raised, growth on human skin. Also called a nevus (nevi, plural).

mutation n. (myoo-TAY-shun)
Change in a gene or chromosome resulting in a new trait or characteristic that can be inherited. Mutation can be a source of beneficial genetic variation, or it can be neutral or harmful in effect.

nevus n. (NEE-vus)
Small, dark, sometimes raised growth on human skin. Also called a mole.

outpatient n.
A patient who receives treatment at a hospital without staying overnight

Phase I, Phase II, Phase III n.

Phase I trial

The first step in testing a new treatment in humans. These studies test the best way to give a new treatment (for example, by mouth, intravenous infusion, or injection) and the best dose. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Because little is known about the possible risks and benefits of the treatments being tested, Phase I trials usually include only a small number of study volunteers.

Phase II trial

In cancer studies, a Phase II trial is a study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.

Phase III trial

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). Phase III trials may include hundreds of people and are designed to prove the safety and efficacy of a new treatment.

placebo n. (pluh-SEE-bo)
Inactive substance that has no treatment value

primary therapy n.
First-line treatment, or the first type of therapy used to treat a disease

protocol n.
A protocol is a study plan on which a clinical trial is based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment

punch biopsy n.
Biopsy technique that involves cutting and removing a disk of tissue

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radiation therapy n.
Treatment of disease using high energy radiation such as X-rays

randomized adj.
Describes an experiment or clinical trial in which animal or human subjects are assigned by chance to separate groups that compare different treatments. In a randomized clinical trial, neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best.

Learn more about a randomized Phase III clinical trial of an experimental treatment for metastatic melanoma.

recur v.
To happen or appear once again or repeatedly

re-excision n.
In the surgical treatment of melanoma, re-excision is a procedure performed when a skin biopsy confirms the presence of melanoma at a site that has already undergone simple excision (surgical removal of the tumor and a margin of normal-looking skin). The re-excision removes even more normal-looking skin from the affected site so that the surrounding tissue can be examined to ensure that no cancer cells remain in the skin.

remission n.
Complete or partial disappearance of the signs and symptoms of disease in response to treatment. The period during which a disease is under control. A remission is not necessarily a cure.

shave biopsy n.
Biopsy technique performed with a surgical blade or a razor blade. This technique is often used for lesions that are elevated above the skin level or confined to the upper layers of skin, or to protrusions of lesions from more internal sites.

side effect n.
Problem that occurs when treatment affects tissues or organs other than the ones meant to be affected by the treatment. Common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss and mouth sores.

simple excision n.
In the surgical treatment of melanoma, simple excision is a procedure in which the tumor, along with a margin of normal-looking skin, is cut out.

skin graft n.
Piece of skin taken from part of the body and used to replace lost or damaged skin

stage n.
The extent to which cancer has spread from its original site to other parts of the body. Stage is usually denoted by a number from stage 0 or I (least severe) to stage IV (more advanced).

standard of care n.
A currently accepted and widely used treatment for a certain disease, based on the results of past research. Also called standard therapy.

sun protection factor (SPF) n.
Degree to which a sun cream, lotion, screen or block provides protection for the skin against the sun

Temodar^® (temozolomide) n. (teh-mo-ZO-lo-mide)
Type of chemotherapy given as a treatment for some types of cancer, especially melanomas

tumor n.
Abnormal uncontrolled growth or mass of body cells, which may be malignant or benign, and has no physiological function

ultraviolet (UV) adj.
Relating to or producing electromagnetic radiation of wavelengths from about 5 nanometers to 400 nanometers, which is beyond the violet end of the visible light spectrum. Ultraviolet radiation refers to radiation with ultraviolet wavelengths. Radiation of this kind is a component of sunlight and is the light that makes exposed skin become darker.

US Food and Drug Administration (FDA) n.
The branch of the US Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs before they can go on the market. The FDA relies on the results of clinical trials that provide reliable information about a treatment’s effects on humans to decided whether or not new drugs should be approved.

When considering a new drug, the FDA faces two challenges: first, making sure that the drug is safe and effective before it is made widely available; and second, ensuring that drugs that show promise are made available as quickly as possible to the people they might help. To deal with these challenges, the FDA maintains a rigorous review process.

vaccine n.
Preparation containing immune-stimulating agents that is administered to trigger an immune response against a specific disease or infection

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X-ray n.
High-energy electromagnetic radiation. It has a wavelength between 0.01 and 10 nanometers, which is between gamma rays and ultraviolet light, and can penetrate solids and ionize gas.

Also, a type of irradiation used for imaging and diagnostic purposes that uses energy beams of very short wavelengths to generate images on photographic film. Dense parts of the body, such as bones, absorb the X-rays and consequently appear as lighter regions on the developed film. It is the most common form of imaging technique used in clinical practice worldwide.

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Sponsored by Antigenics, a biotechnology company that develops cancer vaccines and other treatments for serious illnesses.