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Completed

NCT Number: NCT00106613

A Research Study for Patients With Metastatic Renal Cell Carcinoma

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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Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

City of Hope National Medical Center, Duarte, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FK228 (romidepsin)

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Mar 29, 2005
Registry last updated
Oct 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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