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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 ⁵.

Principal Investigators

Dr. Dao Nguyen and Dr. David Schrump (Protocol Chair), NCI Center for Cancer Research.

Why This Trial Is Important

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 ⁶.

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.

Glossary Terms

A substance being studied in the treatment of several types of cancer. It stops cells from dividing and may kill cancer cells. It is a type of cyclin-dependent kinase (CDK) inhibitor. Also called alvocidib and HMR 1275.

The functional and physical unit of heredity passed from parent to offspring. Genes are pieces of DNA, and most genes contain the information for making a specific protein.

A substance that causes a chemical change that stops tumor cells from dividing. HDAC inhibitors are being studied in the treatment of cancer. Also called HDAC inhibitor.

A rare type of cancer in which malignant cells are found in the lining of the chest or abdomen. Exposure to airborne asbestos particles increases one's risk of developing malignant mesothelioma.

A thin layer of tissue that covers the lungs and lines the interior wall of the chest cavity. It protects and cushions the lungs. This tissue secretes a small amount of fluid that acts as a lubricant, allowing the lungs to move smoothly in the chest cavity while breathing.

Research using animals to find out if a drug, procedure, or treatment is likely to be useful. Preclinical studies take place before any testing in humans is done.

A substance being studied in the treatment of cancer. Romidepsin is a type of depsipeptide and histone deacetylase inhibitor. Also called FR901228 and Istodax.