Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Albert Einstein College of Medicine of Yeshiva University National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00084682 |
RATIONALE: Drugs used in chemotherapy such as FR901228 work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: 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.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer |
Drug: romidepsin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Single Agent Depsipeptide (FK228; NSC 630176; IND51,810) In Patients With Unresectable Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck |
Estimated Enrollment: | 46 |
Study Start Date: | April 2004 |
Estimated Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
Measurable disease
At least 1 unidimensionally measurable lesion > 20 mm by conventional techniques OR > 10 mm by spiral CT scan
Must have disease progression or biopsy proven residual carcinoma if the only site of measurable disease is in a previously irradiated field
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
Bronx, New York, United States, 10461 | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
New York Weill Cornell Cancer Center at Cornell University | |
New York, New York, United States, 10021 |
Study Chair: | Missak Haigentz, MD | Albert Einstein College of Medicine of Yeshiva University |
Study ID Numbers: | CDR0000365527, AECM-02025, NYWCCC-02025, NYWCCC-0402025S, NCI-6335, DFCI-04358 |
Study First Received: | June 10, 2004 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00084682 |
Health Authority: | United States: Food and Drug Administration |
recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity salivary gland squamous cell carcinoma recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity metastatic squamous neck cancer with occult primary squamous cell carcinoma recurrent metastatic squamous neck cancer with occult primary |
recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the oropharynx |
Squamous cell carcinoma Romidepsin Recurrence Carcinoma Epidermoid carcinoma Head and Neck Neoplasms Metastatic squamous neck cancer with occult primary Carcinoma, squamous cell |
Laryngeal carcinoma Hypopharyngeal cancer Neoplasms, Squamous Cell Carcinoma, Squamous Cell Salivary Gland Diseases Carcinoma, squamous cell of head and neck Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents |
Therapeutic Uses Antibiotics, Antineoplastic Pharmacologic Actions |