A Research Study for Patients With Metastatic Renal Cell Carcinoma

Neoplasm Metastasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106613
• Other study ID #: FJ-228-0001
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2003
• Est. completion date: August 1, 2004

Study information

• Verified date: October 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00058630
• NCT00060216

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2004
• Est. primary completion date: August 1, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	City of Hope National Medical Center	Duarte	California
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

References & Publications (6)

Mansfield AS, Jen J. Predicting Treatment Response Based on RNA Expression in Large Datasets. Clin Cancer Res. 2019 Mar 1;25(5):1443-1445. doi: 10.1158/1078-0432.CCR-18-2823. Epub 2018 Nov 16. — View Citation

Moreno L, Casanova M, Chisholm JC, Berlanga P, Chastagner PB, Baruchel S, Amoroso L, Gallego Melcón S, Gerber NU, Bisogno G, Fagioli F, Geoerger B, Glade Bender JL, Aerts I, Bergeron C, Hingorani P, Elias I, Simcock M, Ferrara S, Le Bruchec Y, Slepetis R, Chen N, Vassal G. Phase I results of a phase I/II study of weekly nab-paclitaxel in paediatric patients with recurrent/refractory solid tumours: A collaboration with innovative therapies for children with cancer. Eur J Cancer. 2018 Sep;100:27-34. doi: 10.1016/j.ejca.2018.05.002. Epub 2018 Jun 21. — View Citation

Pal SK, Forero-Torres A, Thompson JA, Morris JC, Chhabra S, Hoimes CJ, Vogelzang NJ, Boyd T, Bergerot PG, Adashek JJ, Li H, Yu X, Gartner EM, Carret AS, Smith DC. A phase 1 trial of SGN-CD70A in patients with CD70-positive, metastatic renal cell carcinoma. Cancer. 2019 Apr 1;125(7):1124-1132. doi: 10.1002/cncr.31912. Epub 2019 Jan 9. — View Citation

Stadler W, et al. A phase II study of depsipeptide (Dep) in patients (pts) with metastatic renal cell cancer (RCC). J Clin Oncol. 2005 Jun; 23(16_suppl):4669.

Stadler WM, Margolin K, Ferber S, McCulloch W, Thompson JA. A phase II study of depsipeptide in refractory metastatic renal cell cancer. Clin Genitourin Cancer. 2006 Jun;5(1):57-60. — View Citation

Wolchok J. Putting the Immunologic Brakes on Cancer. Cell. 2018 Nov 29;175(6):1452-1454. doi: 10.1016/j.cell.2018.11.006. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)).		Up to 6 months
Secondary	Rate of disease control, Complete Response, Partial Response, or Stable Disease		Up to 6 months
Secondary	Time to objective disease progression.		Up to 6 months
Secondary	Number of Participants with Adverse Events		Up to 6 months
Secondary	Change from screening assessment to the final study visit in Karnofsky performance status.		Up to 6 months
Secondary	Steady state plasma concentrations		Up to 6 months