(soruce: phrma.org )

actinic keratoses - Roughness and thickening of the skin caused by overexposure to the sun’s ultraviolet rays. It can degenerate into a skin cancer called squamous cell carcinoma.

 

adenocarcinoma - Malignant tumor derived from a gland or glandular tissue.

 

adjunctive treatment - An auxiliary treatment that is secondary to the main treatment.

 

adjuvant - A substance or drug that aids another substance in its action.

 

allogeneic - Refers to having cell types that are distinct and cause reactions in the immune system. application submitted—An application for marketing has been submitted by the company to the Food and Drug Administration (FDA).

 

ascites - Excess fluid in the space between the tissues lining the abdomen and abdominal organs (the peritoneal cavity).

 

basal cell cancer - Cancer of the lower layers of the skin.

 

B-cell - A class of white blood cells important to the body’s immune system.

 

biliary - Relating to bile.

 

carcinoma - A malignant tumor that arises from epithelial tissues, such as skin.

 

cervical - Relating to the neck of the uterus.

 

chemoprotection - A therapeutic technique in which bone marrow cells are removed from an individual with cancer and are genetically modified to withstand higher doses of chemotherapy before being returned to the donor.

 

cholangiocarcinoma - A malignancy of the biliary duct system that may originate in the liver and extrahepatic bile ducts. More than 90 percent are adenocarcinomas, and the remainder are squamous cell tumors. Cholangiocarcinomas tend to grow slowly and to infiltrate the walls of the ducts. Each year, approximately 2,500 cases occur, and the average incidence is 1 case per 100,000 people per year.

 

cutaneous - Pertaining to the skin. dysplasia—Abnormal tissue development. gastric—Of or relating to the stomach. GIST—Gastrointestinal (GI) stromal cancer is an uncommon tumor of the GI tract. Not all GISTs are cancerous; some are benign. Although these cancers can arise anywhere in the GI tract, they occur most often in the stomach (60% to 70%) and less commonly in the small intestine (20% to 30%). The rest are found in the esophagus, large intestine, rectum, and anus. About 80% of people diagnosed with GIST are older than 50. It is slightly more common in men. Blacks are more likely to develop GISTs than whites.

 

glioblastoma - A fast growing and highly malignant type of brain tumor arising from glial (supporting) cells within the brain. There are about five to 10 new cases per million population per year in the United States.

 

glioma - A type of brain tumor arising from the supporting glial cells within the brain. Gliomas make up about 60 percent of all primary brain tumors and are frequently malignant.

 

graft-versus-host disease (GVHD) - A complication in bone marrow transplants where immune system cells attack the transplant recipient’s tissues.

 

head and neck cancer - The term given to a variety of malignant tumors that develop in the mouth, throat, paranasal sinuses, nasal cavity, larynx, and salivary glands. Many authorities also include skin tumors of the face and neck and tumors of the cervical lymph nodes. There are more than half a million survivors of oral, head, and neck cancer living in the United States today.

 

hematological malignancies - Cancers of the blood or blood-forming tissues, such as leukemia, Hodgkin’s and non-Hodgkin’s lymphomas, AIDS-related malignancies, multiple myeloma, myelodysplasia and myeloproliferative disorders.

 

hepatocellular cancer/carcinoma - A cancer that begins in the liver cells.

 

hyperuricemia - An abnormally high uric acid level in the blood.

 

imaging agent - A substance used to enhance x-ray images of organs and spaces in the body.

 

intraepithelial neoplasia, anal (AIN) & cervical (CIN) - AIN is a consequence of chronic human papillomavirus infection in the anal canal and appears to be driven by high viral loads of human papillomavirus. What is known of its natural history resembles that of cervical intraepithelial neoplasia. Dysplasia and cervical intraepithelial neoplasia (CIN) are different terms or names for the same condition—it is a precursor to cervical cancer. CIN may be mild, moderate or severe.

 

Kaposi’s sarcoma - A rare, malignant skin tumor that occurs in some AIDS patients. It can be accompanied by fever, enlarged lymph nodes and gastrointestinal problems.

 

Leiomyoma - A benign neoplasm derived from smooth muscle.

 

leukemia - A form of cancer in which abnormally growing white blood cells are scattered throughout the body and bone marrow. They can take over the marrow and prevent it from making enough normal blood cells (white, red and platelets), leaving the patient highly susceptible to serious infections, anemia and bleeding episodes. The cells can also spill into the blood, infiltrating and interfering with the function of other organs. The four main types of leukemia are: acute lympho blastic leukemia (ALL), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), and chronic myeloid leukemia (CML). The acute types have a rapid onset, and overwhelming infection or blood loss can cause death. The chronic forms progress much more slowly.

 

lung cancer - The leading cause of cancer deaths in both men and women. There are several types of lung cancer, the most common being squamous cell carcinoma, small (oat) cell carcinoma, adenocarcinoma and large cell carcinoma. Each has a different growth pattern and response to treatment. The squamous cell, small cell and large cell types are all strongly associated with tobacco abuse.

 

lymphoma - Cancers in which the cells of lymphoid tissue, found mainly in the lymph nodes and spleen, multiply unchecked. Lymphomas fall into two categories: Hodgkin disease, characterized by a particular kind of abnormal cell, and non-Hodgkin lymphomas, which vary in their malignancy according to the nature and activity of the abnormal cells. Mantle cell lymphoma is a type of non-Hodgkin lymphoma.

 

macroglobulinemia - A disorder in which plasma cells produce an excessive quantity of macroglobulins (large antibodies) that accumulate in the blood. It results from a group of abnormal, cancerous lymphocytes and plasma cells. Men are affected more often than women, and the average age at onset is 65.

 

mastocytosis - A condition characterized by infiltration of mast cells into the tissues of the body. Mast cells are connective tissue cells which release chemicals including histamine that are very irritating and cause itching, swelling, and fluid leakage from cells.

 

medullary - Relating to the medulla (any soft marrow-like structure, especially the innermost part) or marrow.

 

melanoma - A cancer made up of pigmented (usually brown-colored) skin cells anywhere in the body.

 

mesothelioma - A tumor of the lining of the lung and chest cavity (the pleura).

 

metastases/metastatic - Areas of secondary cancer that have spread from the primary or original cancer site.

 

mucositis - The swelling, irritation, and ulceration of the mucosal cells that line the digestive tract. Mucositis can occur anywhere along the digestive tract from the mouth to the anus. It can be a very troublesome and painful side effect of chemotherapy.

 

multiple myeloma - A malignant condition of middle to old age, characterized by the uncontrolled proliferation and disordered function of plasma cells in the bone marrow. The condition, which makes the patient particularly prone to infection, is rare, with about three new cases annually per 100,000 population.

 

myeloablation - A severe form of myelosuppression, a condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets. It is a side effect of some cancer treatments.

 

myelodysplastic syndromes (MDS) - Blood disorders that ultimately are fatal. Patients usually succumb to infections or bleeding. The term “preleukemia” has been used to describe these disorders.

 

neoadjuvant therapy - Chemotherapy, radiation therapy, or hormone therapy given before the primary or main treatment. Neo-adjuvant therapy, like chemotherapy and radiation therapy, is often given before surgery to reduce the size of a tumor or to make surgery less complicated.

 

neuroblastoma - A tumor of the adrenal glands or sympathetic nervous system (the part of the nervous system responsible for certain automatic body functions, such as the control of heart rate). Neuroblastomas are the most common extracranial (outside the skull) solid tumors of childhood.

 

osteosarcoma - Cancer of the bone that occurs predominantly in adolescents and young adults. It accounts for 5 percent of cancer in children.

 

peritoneal - Relating to the peritoneum, the membrane that lines the abdominal cavity and covers most of the abdominal organs.

 

Phase 0 - First-in-human trials conducted in accordance with FDA’s 2006 guidance on exploratory Investigational New Drug (IND) studies designed to speed up development of promising drugs by establishing very early on whether the agent behaves in human subjects as was anticipated from preclinical studies

 

Phase I - Safety testing and pharmacological profiling of new drugs in small numbers of humans.

 

Phase II - Effectiveness testing and identification of side effects of new drugs in humans.

 

Phase III - Extensive clinical trials in humans to verify effectiveness and monitor adverse reactions of new drugs.

 

prolactinoma - A noncancerous pituitary tumor that produces a hormone called prolactin, which results in too much prolactin in the blood.

 

refractory - Resistant to treatment or cure.

 

sarcoma - A malignant tumor that arises from deep body tissues, such as muscle, bone or fibrous tissue.

 

T-cell - One of two main classes of white blood cells called lymphocytes, which are important to the body’s disease-fighting immune system.

 

thrombocytopenia - A reduction in the number of platelet cells in the blood, which causes a tendency to bleed, especially from the smaller blood vessels.

 

thymoma - Although rare, thymomas are the most common tumor of the thymus, a small organ located in the upper chest just below the neck that produces certain types of white blood cells (lymphocytes) before birth and during childhood. Thymomas arise from thymic epithelial cells, which make up the covering of the thymus. Up to 40 percent of thymomas are invasive. They affect men and women equally and are usually diagnosed between the ages of 40 and 60. Thymomas are uncommon in children.

 

unresectable - Unable to be removed (resected) by surgery.