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 at http://cancer.gov/clinicaltrials/NCI-07-C-0097.

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 at http://cancer.gov/clinicaltrials/NCI-07-C-0097 or call the NCI Clinical Trials Referral Office at 888-624-1937. The call is toll free and confidential.

An archive of "Featured Clinical Trial" columns is available at http://www.cancer.gov/clinicaltrials/ft-all-featured-trials.