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Batracylin for Patients with Advanced Solid Tumors or Lymphoma
Untitled Document
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.
Principal Investigator
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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 or call the NCI Clinical Trials Referral
Office at 1-888-NCI-1937. The call is toll free and confidential.
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