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FR901228 in Treating Patients With Unresectable Recurrent or Metastatic Squamous Cell Carcinoma (Cancer) of the Head and Neck
This study is ongoing, but not recruiting participants.
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
  Purpose

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

MedlinePlus related topics: Cancer Head and Neck Cancer
Drug Information available for: FR 901228
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease control (complete response, partial response, or stable disease) as measured by RECIST criteria after 2 courses [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: April 2004
Estimated Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the rate of disease control (i.e., achievement of complete response, partial response, or stable disease) in patients with unresectable recurrent or metastatic squamous cell carcinoma of the head and neck treated with FR901228 (depsipeptide).

Secondary

  • Determine the duration of response, time to disease progression, and overall survival of patients treated with this drug.
  • Correlate the extent of drug activity with tumor response in these patients.
  • Determine changes in the gene expression profile of tumor cells and buccal mucosa cells in patients treated with this drug.
  • Determine changes in methylation of candidate genes in tumor cells and buccal mucosa epithelia in patients treated with this drug.
  • Determine altered expression of signaling and cell cycle-related proteins in tumor tissue in patients treated with this drug.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed squamous cell carcinoma of the head and neck

    • Unresectable recurrent or metastatic disease
    • No nasopharyngeal primaries
  • Incurable with surgery or radiotherapy
  • 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

        • Persistent disease after radiotherapy must be biopsy proven at least 8 weeks after the completion of radiotherapy
  • Accessible to planned biopsy methods
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • WBC ≥ 3,000/mm^3
  • Hemoglobin ≥ 10 g/dL

Hepatic

  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • PT and PTT ≤ 1.1 times ULN

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min
  • Calcium normal
  • Uric acid normal

Cardiovascular

  • QTc ≤ 500 msec
  • CPK and troponin normal
  • No significant cardiac disease
  • No history of cardiac hypertrophy
  • No history of serious ventricular arrhythmias (ventricular tachycardia or ventricular fibrillation > 3 beats in a row)
  • No atrial fibrillation
  • No uncontrolled dysrhythmias
  • No poorly controlled angina
  • No myocardial infarction within the past year
  • No New York Heart Association class III or IV congestive heart failure

Other

  • Potassium ≥ 4 mmol/L
  • Magnesium ≥ 2 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active or ongoing infection
  • No other concurrent uncontrolled illness
  • No psychiatric illness or social situation the would preclude study compliance
  • No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent biologic agents

Chemotherapy

  • More than 4 weeks since prior chemotherapy, including palliative chemotherapy, (6 weeks for mitomycin or nitrosoureas) and recovered
  • No prior cumulative dose of doxorubicin more than 450 mg/m^2
  • No prior FR901228 (depsipeptide)
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery

Other

  • No concurrent therapy for infection
  • No concurrent agents that cause QTc prolongation
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent hydrochlorothiazide
  • No other concurrent drugs with histone deacetylase inhibitor activity (e.g., sodium valproate)
  • No other concurrent antineoplastic or investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084682

Locations
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
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Study Chair: Missak Haigentz, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Haigentz M Jr, Adrien LR, Belbin TJ, et al.: Translational studies of depsipeptide (romidepsin, FK228), a histone deacetylase (HDAC) inhibitor, in patients with head and neck cancer. [Abstract] American Association for Cancer Research: 98th Annual Meeting, April 14-18, 2007, Los Angeles, CA. A-3524, 2007.
Haigentz M Jr, Kim M, Sarta C, et al.: Clinical and translational studies of depsipeptide (romidepsin), a histone deacetylase (HDAC) inhibitor, in patients with squamous cell carcinoma of the head and neck (SCCHN): New York Cancer Consortium trial P6335. [Abstract] J Clin Oncol 25 (Suppl 18): A-6065, 315s, 2007.

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009