Clinical trial NCT00106613: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Neoplasm Metastasis
Keywords: Renal Cell Carcinoma
Metastatic Cancer
Metastatic Renal Cell Carcinoma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2005-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)).
timeFrame: Up to 6 months
Secondary outcomes:
measure: Rate of disease control, Complete Response, Partial Response, or Stable Disease
timeFrame: Up to 6 months
measure: Time to objective disease progression.
timeFrame: Up to 6 months
measure: Number of Participants with Adverse Events
timeFrame: Up to 6 months
measure: Change from screening assessment to the final study visit in Karnofsky performance status.
timeFrame: Up to 6 months
measure: Steady state plasma concentrations
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: Gloucester Pharmaceuticals Inc.
name: William McCulloch, MB, FRCP
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.