Back to resultsA Research Study for Patients With Metastatic Renal Cell Carcinoma
Primary Purpose
Carcinoma, Renal Cell, Neoplasm Metastasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FK228 (romidepsin)
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Renal Cell Carcinoma, Metastatic Cancer, Metastatic Renal Cell Carcinoma
Eligibility 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
Sites / Locations
- City of Hope National Medical Center
- University of Chicago
- Seattle Cancer Care Alliance
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FK228 (romidepsin)
Arm Description
13 mg/m2 of romidepsin
Outcomes
Primary Outcome Measures
To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)).
Secondary Outcome Measures
Rate of disease control, Complete Response, Partial Response, or Stable Disease
Time to objective disease progression.
Number of Participants with Adverse Events
Change from screening assessment to the final study visit in Karnofsky performance status.
Steady state plasma concentrations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00106613
Brief Title
A Research Study for Patients With Metastatic Renal Cell Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2003 (Actual)
Primary Completion Date
August 1, 2004 (Actual)
Study Completion Date
August 1, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell, Neoplasm Metastasis
Keywords
Renal Cell Carcinoma, Metastatic Cancer, Metastatic Renal Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FK228 (romidepsin)
Arm Type
Experimental
Arm Description
13 mg/m2 of romidepsin
Intervention Type
Drug
Intervention Name(s)
FK228 (romidepsin)
Other Intervention Name(s)
romidepsin
Intervention Description
Patients receive 13 mg/m2 of romidepsin (FK228) intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
Primary Outcome Measure Information:
Title
To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)).
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Rate of disease control, Complete Response, Partial Response, or Stable Disease
Time Frame
Up to 6 months
Title
Time to objective disease progression.
Time Frame
Up to 6 months
Title
Number of Participants with Adverse Events
Time Frame
Up to 6 months
Title
Change from screening assessment to the final study visit in Karnofsky performance status.
Time Frame
Up to 6 months
Title
Steady state plasma concentrations
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William McCulloch, MB, FRCP
Organizational Affiliation
Gloucester Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29936064
Citation
Moreno L, Casanova M, Chisholm JC, Berlanga P, Chastagner PB, Baruchel S, Amoroso L, Gallego Melcon 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.
Results Reference
background
PubMed Identifier
30500529
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.
Results Reference
background
PubMed Identifier
30446588
Citation
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.
Results Reference
background
PubMed Identifier
30624766
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
16859580
Citation
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. doi: 10.3816/CGC.2006.n.018.
Results Reference
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A Research Study for Patients With Metastatic Renal Cell Carcinoma
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