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Combining Targeted Therapies for Thoracic Cancers
Untitled Document
Name of the Trial
Phase I Study of Romidepsin (Depsipeptide; FK228; FR901228) and Flavopiridol
in Patients With Advanced Primary Lung or Esophageal Cancer, Malignant Pleural
Mesothelioma, or Lung or Pleural Metastases (NCI-05-C-0010). See the protocol
summary.
Principal Investigators
Dr. Dao Nguyen and Dr. David Schrump (Protocol Chair), NCI Center for Cancer
Research.
Why This Trial Is Important
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Dr. Dao Nguyen
Principal Investigator |
Romidepsin is a new anticancer agent that belongs to a family of drugs called
histone deacetylase inhibitors. These drugs can turn on genes in cancer cells
that regulate cell growth and induce cell death (apoptosis). Unfortunately,
the protein product of one of the genes activated by romidepsin, called p21,
also interferes with the drug's ability to induce apoptosis. Researchers think
that combining romidepsin with other anticancer drugs may improve its ability
to kill cancer cells.
The drug flavopiridol has been shown to have a weak anticancer effect. However,
when administered to cancer cells treated with romidepsin, it suppresses the
expression of the p21 gene and increases the anticancer effect of romidepsin.
Laboratory studies that combined romidepsin and flavopiridol demonstrated that
the combination was up to 10 times better at inducing apoptosis in lung and
esophageal tumor cells than either agent alone.
In this trial, patients with advanced thoracic cancers (cancers of the chest)
or other cancers that have spread to the chest will be treated with romidepsin
and flavopiridol. Researchers will study the safety of this combination and
how these agents affect gene and protein expression in these patients.
"Based on our preclinical studies, we believe that combining these agents
will dramatically improve the cancer cell killing power of romidepsin in thoracic
cancers and potentially in a broad range of solid tumors," said Dr. Nguyen.
Who Can Join This Trial
Researchers will recruit 48 patients aged 18 or over with advanced lung cancer,
esophageal cancer, malignant mesothelioma, or nonthoracic cancer that has metastasized
to the lungs or pleura. See the list
of eligibility criteria.
Study Site and Contact Information
The study is taking place at the NIH Clinical Center in Bethesda, Md. For more
information about this trial, call the NCI Clinical Studies Support Center toll-free
at 1-888-NCI-1937. This call is confidential.
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