NCI 6335

Principal Investigator:	Bruce Culliney, MD
Time frame of study:	Ongoing
Location of Study:	Beth Israel Medical Center St.Luke's-Roosevelt Hospital Center
Contact:	Continuum Cancer Research Program (212) 844-6286

Summary:
Currently, there is no standard of care for patients with unresectable recurrent or metastatic head and neck cancer. Depsipeptide is a strong inhibitor of histone deacetylase (an enzyme that changes the way histones – proteins – bind to DNA). Deregulation of this enzyme has been implicated in the development of several types of cancer. These findings suggest that this deregulation of proteins plays a role in the formation of blood cancers as well as solid tumors by changing the structure and transcription (replication) of genes involved in cell cycle, differentiation (how cells become what they are, e.g. neurons, cardiac cells, etc) or apoptosis (cell death). Consequently, there is considerable interest in histone deacetylase inhibition as a potential therapeutic option in the treatment of blood cancers and solid tumors.

Eligibility and Treatment Plan:
Patients, 18 years and older, with histologically or cytologically confirmed squamous cell cancer of the head and neck, excluding nasopharyngeal primaries, which is unresectable or metastatic. The disease must be incurable with surgery or radiation therapy, and patients must have measurable disease. Please call for more information.

Depsipeptide will be administered on an outpatient basis as a 4-hour infusion on days 1, 8, and 15 of each 28-day cycle. A treatment cycle of therapy will be defined as 28 days, and 4 cycles are planned. Depsipeptide will be administered via a central venous catheter, PICC line (peripherally inserted central catheter) or peripheral IV line (through a vein).

Benefits and/or Compensation:
Participants receive study-related medication at no charge under the supervision and care of a team of medical professionals. The information gathered from this study may be beneficial to future patients, and depsipeptide may improve overall survival time for metastatic head and neck squamous cell cancer patients.