Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00084682

Depsipeptide in Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Stage IV Squamous Cell Carcinoma of the Hypopharynx Clinical Trial

Official title:
A Phase II Study of Single Agent Depsipeptide (FK228; NSC 630176; IND 51,810) in Patients With Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Clinical Trial Summary

This phase II trial is studying how well FR901228 works in treating patients with unresectable recurrent or metastatic squamous cell carcinoma (cancer) of the head and neck. Drugs used in chemotherapy such as FR901228 work in different ways to stop tumor cells from dividing so they stop growing or die.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To evaluate the rate of disease control (i.e., achievement of complete response, partial response, or stable disease) of the single agent depsipeptide in patients with unresectable recurrent or metastatic squamous cell carcinoma of the head and neck. SECONDARY OBJECTIVES: I. To evaluate the duration of response, time to progression, and overall survival for patients with incurable head and neck cancer treated with depsipeptide. TERTIARY OBJECTIVES: I. To determine the extent of histone hyperacetylation in peripheral blood mononuclear cells (PBMCs) as a readout of depsipeptide activity before and after depsipeptide administration, to correlate this activity with observed histone hyperacetylation in tumor and mucosal cells, and to correlate extent of depsipeptide activity with tumor response. II. To determine depsipeptide-induced changes in the gene expression profile of tumor cells from biopsies of accessible tumor tissue and of mucosal cells from transepithelial oral brush biopsies using cDNA microarrays containing 28,000 clones, and to correlate these changes with extent of histone hyperacetylation observed in PBMCs and tumor tissues. III. To determine depsipeptide-induced changes in methylation of candidate genes in tumor cells and oral mucosa epithelia. IV. To demonstrate altered expression of signaling and cell cycle-related proteins in tumor tissue in response to depsipeptide. OUTLINE: This is a multicenter study. Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Squamous Cell Carcinoma of Head and Neck
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IV Squamous Cell Carcinoma of the Larynx
  • Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IV Squamous Cell Carcinoma of the Oropharynx
Clinical Trial Details
NCT number NCT00084682
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date June 2005
Completion date March 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT01469429 - Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer. Phase 1/Phase 2
Completed NCT01155609 - L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer N/A
Completed NCT00049283 - Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer Phase 1
Completed NCT01044433 - Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck Phase 2
Completed NCT00407810 - Cetuximab and Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Phase 2
Completed NCT00098631 - Lapatinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer Phase 2
Completed NCT00096512 - S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Phase 2
Completed NCT00055770 - Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Head and Neck Cancer Phase 1/Phase 2
Terminated NCT01249443 - Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection Phase 1
Completed NCT01637194 - Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer Phase 1
Completed NCT00033618 - Ixabepilone in Treating Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck Phase 2
Completed NCT01816984 - PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Phase 1/Phase 2
Withdrawn NCT01674374 - Botanical Therapy in Treating Mucositis in Patients With Head and Neck Cancer Who Have Undergone Chemoradiation Therapy Phase 2
Terminated NCT01528137 - Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck Cancer Phase 1
Terminated NCT02177838 - Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer N/A
Completed NCT00114283 - Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer Phase 2
Completed NCT00055913 - Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Phase 1/Phase 2
Terminated NCT01682031 - Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy Phase 2
Completed NCT00492089 - Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer Phase 2
Completed NCT00410826 - Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer Phase 2