A Research Study for Patients With Metastatic Renal Cell Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-01

Study Completion Date

2004-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Carcinoma, Renal Cell Neoplasm Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FK228 (romidepsin)

13 mg/m2 of romidepsin

Group Type EXPERIMENTAL

FK228 (romidepsin)

Intervention Type DRUG

Patients receive 13 mg/m2 of romidepsin (FK228) intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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romidepsin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No