Thymoma Clinical Trial
Official title:
A Phase II Study of Amrubicin in Relapsed or Refractory Thymic Malignancies
A research study of the drug amrubicin in patients with cancer of the thymus (thymoma or thymic carcinoma). We hope to learn whether this drug is an effective and safe treatment for thymic cancers.
Amrubicin, a synthetic 9-aminoanthracycline, is structurally similar to doxorubicin, but has
a different primary mode of action. It acts primarily as an inhibitor of DNA topoisomerase
II, exerting its cytotoxic effects by stabilizing a topoisomerase II mediated cleavable
complex. This inhibition is significantly more than that seen in doxorubicin, which, in
contrast, tends to demonstrate more DNA intercalation than amrubicin.
It has not yet been evaluated for use in thymic malignancies, but given its efficacy in NSCLC
and small cell lung cancer (SCLC), as well as the known efficacy of other anthracyclines and
topoisomerase II inhibitors in first-line thymoma treatment, it warrants study for use in the
second line and beyond in refractory or relapsed patients. Unlike doxorubicin, amrubicin has
had minimal cardiotoxicity even with ongoing use, which also makes it a promising agent for
use in the second line even for patients who have previously been exposed to, and potentially
helped by, doxorubicin.
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