A Research Study for Patients With Metastatic Renal Cell Carcinoma

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT00106613

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

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 :

Aug 1, 2004

Actual Study Completion Date :

Aug 1, 2004

Arms and Interventions

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 Names: romidepsin

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 Names:

romidepsin

Outcome Measures

Primary Outcome Measures

To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)). [Up to 6 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	City of Hope National Medical Center	Duarte	California	United States	91010
2	University of Chicago	Chicago	Illinois	United States	60637
3	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109-1023