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A Research Study for Patients With Metastatic Renal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00106613
First received: March 28, 2005
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Carcinoma, Renal Cell
Neoplasm Metastasis
 Drug: FK228 (romidepsin)
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Romidepsin
U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)). [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of disease control, Complete Response, Partial Response, or Stable Disease [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Time to objective disease progression. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
  • Change from screening assessment to the final study visit in Karnofsky performance status. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Steady state plasma concentrations [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2003
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106613

Locations
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
Celgene Corporation
Investigators
Study Director: William McCulloch, MB, FRCP Gloucester Pharmaceuticals Inc.
  More Information

Publications:

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00106613     History of Changes
Obsolete Identifiers: NCT00058630, NCT00060216
Other Study ID Numbers: FJ-228-0001
Study First Received: March 28, 2005
Last Updated: August 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Renal Cell Carcinoma
Metastatic Cancer
Metastatic Renal Cell Carcinoma

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Renal Cell
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Romidepsin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013