COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

A Research Study for Patients With Metastatic Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00106613
Recruitment Status : Completed
First Posted : March 29, 2005
Last Update Posted : October 18, 2019
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate the activity of FK228 in metastatic renal cell carcinoma (RCC) patients who have developed progressive disease (PD) following or during treatment with immunotherapy.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Neoplasm Metastasis Drug: FK228 (romidepsin) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Phase II, Multicenter, Open-label Trial Evaluating the Activity and Tolerability of FK228 in Patients With Metastatic Renal Cell Carcinoma That is Progressive Following or During Immunotherapy
Actual Study Start Date : May 1, 2003
Actual Primary Completion Date : August 1, 2004
Actual Study Completion Date : August 1, 2004

Arm Intervention/treatment
Experimental: FK228 (romidepsin)
13 mg/m2 of romidepsin
Drug: FK228 (romidepsin)
Patients receive 13 mg/m2 of romidepsin (FK228) intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
Other Name: romidepsin

Primary Outcome Measures :
  1. To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)). [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. Rate of disease control, Complete Response, Partial Response, or Stable Disease [ Time Frame: Up to 6 months ]
  2. Time to objective disease progression. [ Time Frame: Up to 6 months ]
  3. Number of Participants with Adverse Events [ Time Frame: Up to 6 months ]
  4. Change from screening assessment to the final study visit in Karnofsky performance status. [ Time Frame: Up to 6 months ]
  5. Steady state plasma concentrations [ Time Frame: Up to 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients must fulfill all of the following criteria to be eligible for study participation:

  • Age ≥ 18 years;
  • Histologically confirmed Renal Cell Carcinoma (RCC);
  • Metastatic disease, with measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST);
  • Failure of prior cytokine therapy;
  • Documented progressive disease;

Exclusion Criteria:

Patients are ineligible for entry if any of the following criteria are met:

  • Significant cardiac disease including congestive heart failure, history of myocardial infarction within one year, uncontrolled dysrhythmias, or poorly controlled angina
  • History of serious ventricular arrhythmia
  • Corrected QT interval (QTc) ≥ 500 msec
  • Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C;
  • Previous extensive radiotherapy involving ≥ 30% of bone marrow
  • Coexistent second malignancy or history of prior malignancy within previous 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00106613

Layout table for location information
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Layout table for investigator information
Study Director: William McCulloch, MB, FRCP Gloucester Pharmaceuticals Inc.

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Celgene Identifier: NCT00106613    
Obsolete Identifiers: NCT00058630, NCT00060216
Other Study ID Numbers: FJ-228-0001
First Posted: March 29, 2005    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Keywords provided by Celgene:
Renal Cell Carcinoma
Metastatic Cancer
Metastatic Renal Cell Carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents