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

NCT00084682 | Completed Phase 2 Results DMC

• 3 other identifiers: NCI-2013-00027MMC 04-02-025SN01CM62204
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Disease Control (i.e., Achievement of Complete Response, Partial Response, or Stable Disease)

  Tumor response was assessed every eight weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions as assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable disease (SD) was defined as having no evidence of response (CR or PR) as best response to therapy, and no evidence of disease progression (appearance of new lesions or \>/= 30% increase in target lesions) at 8 weeks.

  Up to 2 years

Secondary Outcomes (3)

• Duration of Response

  Up to 2 years

• Time to Progression

  Up to 2 years

• Overall Survival

  Up to 2 years

Study Arms (1)

Treatment (romidepsin)

EXPERIMENTAL

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.

Drug: romidepsin

Interventions

romidepsin DRUG

Given IV

Also known as: FK228, FR901228, Istodax

Treatment (romidepsin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically or cytologically confirmed squamous cell cancer of the head and neck (MedDRA code 90002024), excluding nasopharyngeal primaries, which is unresectable or metastatic; the disease must be incurable with surgery or radiation therapy; the tumor should preferably be present at the primary site, and it must be accessible to planned biopsy methods
• Measurable disease by RECIST,
• May have received any number of prior systemic chemotherapy regimen for unresectable, recurrent or metastatic disease; if the only site of measurable disease is a previously irradiated area, the patient must have documented progressive disease or biopsy-proven residual carcinoma; persistent disease after radiotherapy must be biopsy-proven at least 8 weeks after the completion of radiotherapy
• Life expectancy of greater than 3 months
• Normal organ and marrow function as defined by the following labs performed =\< 2 weeks of study entry:
• Leukocytes ≥ 3,000/uL
• Absolute Neutrophil Count ≥ 1,500/uL
• Hemoglobin ≥ 10 gm%
• Platelets ≥ 100,000/uL
• Total Bilirubin =\< 1.5 X upper normal institutional limit
• AST(SGOT)/ALT(SGPT) =\< 2.5 X upper normal institutional limits
• Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
• PT/PTT =\< 1.1X upper normal institutional limits
• Calcium within normal institutional limits
• CPK, Troponin within normal institutional limits

You may not qualify if:

• Patients should not have had prior therapy with depsipeptide and may not be receiving any other investigational agents or drugs known to have histone deacetylase inhibitor activity such as sodium valproate
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• Significant cardiac disease including congestive heart failure that meets New York Heart Association (NYHA) class III and IV definitions (see Appendix II), history of myocardial infarction within one year of study entry, uncontrolled dysrhythmias, or poorly controlled angina
• History of serious ventricular arrhythmia (VT or VF, \> 3 beats in a row), QTc \> 500 msec, or LVEF \< 40%
• Patients may not be co-medicated with an agent that causes QTc prolongation; - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
• Not pregnant or lactating
• History of HIV infection

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467-2490, United States

Location

Related Publications (1)

• Haigentz M Jr, Kim M, Sarta C, Lin J, Keresztes RS, Culliney B, Gaba AG, Smith RV, Shapiro GI, Chirieac LR, Mariadason JM, Belbin TJ, Greally JM, Wright JJ, Haddad RI. Phase II trial of the histone deacetylase inhibitor romidepsin in patients with recurrent/metastatic head and neck cancer. Oral Oncol. 2012 Dec;48(12):1281-8. doi: 10.1016/j.oraloncology.2012.05.024. Epub 2012 Jun 28.

  PMID: 22748449 RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: Lisa Escobar-Peralta
• Organization: Montefiore Medical Center

lescobar@montefiore.org

718-379-6866

Study Officials

• Missak Haigentz

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: June 1, 2005
• Primary Completion: November 1, 2008
• Study Completion: March 1, 2012
• Last Updated: March 5, 2021
• Results First Posted: May 19, 2015

Record last verified: 2021-02

Locations

US (2)