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Name of the Trial

Phase I Study of Cediranib in Pediatric Patients With Refractory or Recurrent Extracranial Malignant Solid Tumors or Acute Myeloid Leukemia (NCI-06-C-0152). See the protocol summary ³.

Principal Investigator

Dr. Elizabeth Fox, NCI Center for Cancer Research.

Why This Trial Is Important

Great progress has been made in the treatment of childhood cancers over the past thirty years, thanks primarily to advances in chemotherapy and a high level of participation in clinical trials by pediatric patients. This progress, however, is in danger of stalling without new treatment advances.

One approach that has shown effectiveness in the treatment of some adult cancers is inhibiting the growth of new blood vessels to tumors (i.e., blocking tumor angiogenesis). Without angiogenesis, solid tumors are unable to grow beyond a few millimeters in size. Because drugs that inhibit angiogenesis may cause different side effects in children than they do in adults, it is important to carefully test their use in pediatric cancer patients.

In this trial, researchers are testing an angiogenesis inhibitor called cediranib in pediatric patients who have solid tumors (except brain tumors) or acute myeloid leukemia (AML), a type of blood cancer. Although solid tumors are not formed in AML, there is evidence that a protein known to be important in tumor angiogenesis (i.e., vascular endothelial growth factor, or VEGF) may also be important for the growth of AML cells. Cediranib blocks all three known receptor proteins for VEGF.

"Solid tumors in children tend to be highly vascular, and adult AML patients with elevated levels of VEGF typically don't survive as long as those with lower levels," said Dr. Fox. "So, there's a strong rationale for using VEGF inhibitors for these cancers. However, it is vitally important to assess the toxicities and establish the appropriate dosage of cediranib for pediatric patients.

"Furthermore, we plan to study how cediranib affects a number of markers related to cancer progression and, at least preliminarily, determine tumor responses to cediranib in these patients," she added.

For More Information

See the lists of eligibility criteria and study sites ³ or call the NCI Clinical Trials Referral Office at 1-888-NCI-1937. The toll-free call is confidential.

Glossary Terms

An aggressive (fast-growing) disease in which too many myeloblasts (immature white blood cells that are not lymphoblasts) are found in the bone marrow and blood. Also called acute myeloblastic leukemia, acute myelogenous leukemia, acute nonlymphocytic leukemia, AML, and ANLL.

A substance that may prevent the formation of blood vessels. In anticancer therapy, an angiogenesis inhibitor may prevent the growth of new blood vessels that tumors need to grow.

A molecule inside or on the surface of a cell that binds to a specific substance and causes a specific physiologic effect in the cell.

A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

An abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign (not cancer), or malignant (cancer). Different types of solid tumors are named for the type of cells that form them. Examples of solid tumors are sarcomas, carcinomas, and lymphomas. Leukemias (cancers of the blood) generally do not form solid tumors.

A substance that may be found in tumor tissue or released from a tumor into the blood or other body fluids. A high level of a tumor marker may mean that a certain type of cancer is in the body. Examples of tumor markers include CA 125 (in ovarian cancer), CA 15-3 (in breast cancer), CEA (in ovarian, lung, breast, pancreas, and gastrointestinal tract cancers), and PSA (in prostate cancer).