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 at http://cancer.gov/clinicaltrials/NCI-05-C-0010.

Principal Investigators
Drs. Dao Nguyen and David Schrump (Protocol Chair), NCI's CCR

Why This Trial Is Important
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 at http://cancer.gov/clinicaltrials/NCI-05-C-0010.

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.