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Name of the Trial

Phase I Study of Batracylin in Patients With Metastatic or Unresectable Solid Tumors or Lymphoma (NCI-07-C-0097). See the protocol summary ².

Principal Investigator

Dr. Martin Gutierrez Principal Investigator

Dr. Martin Gutierrez, NCI Center for Cancer Research.

Why This Trial Is Important

Scientists have made great strides in determining how certain proteins contribute to cancer formation, growth, and spread. As a result, the development of drugs that target these proteins has become a major focus of cancer research.

Along with the development of such targeted therapies, researchers have explored the possibility of matching the genetic characteristics of patients to treatments that may be especially suited to them. The drug batracylin is an example of a targeted therapy that may prove beneficial to patients with certain genetic characteristics.

Batracylin inhibits two proteins, topoisomerase I and topoisomerase II, that are overabundant in certain types of cancer cells and may play a role in cancer formation and progression. Drugs have been developed that target one or the other of these proteins, but batracylin is the first drug to reach human clinical trials that targets them both.

Although this ability makes batracylin a promising anticancer agent, early testing in animals indicated that different species process the drug differently, with some species processing it very quickly, resulting in unacceptably severe side effects. Subsequent research showed that a cellular process called acetylation occurs more rapidly in these species, causing them to process batracylin more quickly. This finding led researchers to theorize that humans whose genetic characteristics cause slow acetylation would be able to tolerate and benefit from treatment with batracylin.

In this trial, patients with solid tumors or lymphomas for which standard therapies do not exist or are of minimum benefit and who are slow acetylators, as determined by a blood test, will be treated with increasing doses of batracylin. Researchers hope to assess the pharmacokinetics of batracylin in these patients and determine the most appropriate dose for future clinical trials.

For More Information

See the list of entry criteria and trial contact information ² or call the NCI Clinical Trials Referral Office at 1-888-NCI-1937. The call is toll free and confidential.

Glossary Terms

A substance being studied in the treatment of cancer. It may kill cancer cells by causing damage to the DNA. Batracylin is a type of heterocyclic aryl amine.

Cancer that begins in cells of the immune system. There are two basic categories of lymphomas. One kind is Hodgkin lymphoma, which is marked by the presence of a type of cell called the Reed-Sternberg cell. The other category is non-Hodgkin lymphomas, which includes a large, diverse group of cancers of immune system cells. Non-Hodgkin lymphomas can be further divided into cancers that have an indolent (slow-growing) course and those that have an aggressive (fast-growing) course. These subtypes behave and respond to treatment differently. Both Hodgkin and non-Hodgkin lymphomas can occur in children and adults, and prognosis and treatment depend on the stage and the type of cancer.

The activity of drugs in the body over a period of time, including the processes by which drugs are absorbed, distributed in the body, localized in the tissues, and excreted.

A molecule made up of amino acids that are needed for the body to function properly. Proteins are the basis of body structures such as skin and hair and of substances such as enzymes, cytokines, and antibodies.

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 type of treatment that uses drugs or other substances, such as monoclonal antibodies, to identify and attack specific cancer cells. Targeted therapy may have fewer side effects than other types of cancer treatments.