scholarly journals Phase I Study Combining Treatment with Temsirolimus and Sunitinib Malate in Patients with Advanced Renal Cell Carcinoma

2009 ◽  
Vol 7 (1) ◽  
pp. 24-27 ◽  
Author(s):  
Premal H. Patel ◽  
Peggy L. Senico ◽  
Rafael E. Curiel ◽  
Robert J. Motzer
Keyword(s):  
Renal Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Phase I Study ◽  
Advanced Renal Cell Carcinoma ◽  
Sunitinib Malate

scholarly journals Phase I study combining treatment with temsirolimus and sunitinib malate in patients with advanced renal cell carcinoma

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 16020-16020 ◽  
Author(s):  
P. Fischer ◽  
P. Patel ◽  
M. A. Carducci ◽  
D. F. McDermott ◽  
G. R. Hudes ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Phase I Study ◽  
Advanced Renal Cell Carcinoma ◽  
Sunitinib Malate

scholarly journals Phase I study of the mTOR inhibitor ridaforolimus and the HDAC inhibitor vorinostat in advanced renal cell carcinoma and other solid tumors

2015 ◽  
Vol 33 (5) ◽  
pp. 1040-1047 ◽  
Author(s):  
Matthew Zibelman ◽  
Yu-Ning Wong ◽  
Karthik Devarajan ◽  
Lois Malizzia ◽  
Alycia Corrigan ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Solid Tumors ◽  
Hdac Inhibitor ◽  
Renal Cell ◽  
Phase I Study ◽  
Mtor Inhibitor ◽  
Advanced Renal Cell Carcinoma

scholarly journals A Phase I Study of High-Dose Interleukin-2 With Sorafenib in Patients With Metastatic Renal Cell Carcinoma and Melanoma

2014 ◽  
Vol 37 (3) ◽  
pp. 180-186 ◽  
Author(s):  
Paul Monk ◽  
Elaine Lam ◽  
Amir Mortazavi ◽  
Kari Kendra ◽  
Gregory B. Lesinski ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Phase I Study ◽  
Interleukin 2 ◽  
High Dose

Phase I study of axitinib and everolimus in metastatic solid tumours and extension to metastatic renal cell carcinoma: Results of EVAX study

2017 ◽  
Vol 85 ◽  
pp. 39-48 ◽  
Author(s):  
Alain Ravaud ◽  
Carlos Gomez-Roca ◽  
Marie-Quitterie Picat ◽  
Laurence Digue ◽  
Christine Chevreau ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Phase I Study ◽  
Solid Tumours

scholarly journals Phase I Study of Nivolumab in Combination with Ipilimumab in Metastatic Renal Cell Carcinoma (Mrcc)

2014 ◽  
Vol 25 ◽  
pp. iv361 ◽  
Author(s):  
H. Hammers ◽  
E.R. Plimack ◽  
J.R. Infante ◽  
M. Ernstoff ◽  
B.I. Rini ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Phase I ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Phase I Study

Phase I Trial of 40-kd Branched Pegylated Interferon Alfa-2a for Patients With Advanced Renal Cell Carcinoma

2001 ◽  
Vol 19 (5) ◽  
pp. 1312-1319 ◽  
Author(s):  
Robert J. Motzer ◽  
Ashok Rakhit ◽  
Michelle Ginsberg ◽  
Karen Rittweger ◽  
Jacqueline Vuky ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Serum Concentration ◽  
Phase I ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Subcutaneous Administration ◽  
Interferon Alfa ◽  
Advanced Renal Cell Carcinoma ◽  
Grade 3 ◽  
Dose Limiting Toxicity

PURPOSE: Pegylated (40 kd) interferon alfa-2a (IFNα2a) (PEGASYS, Hoffman-La Roche, Nutley, NJ; PEG-IFN) is a modified form of recombinant human IFNα2a with sustained absorption and prolonged half-life after subcutaneous administration. A phase I study of PEG-IFN with pharmacokinetic and pharmacodynamic evaluations was conducted in previously untreated patients with advanced renal cell carcinoma (RCC). PATIENTS AND METHODS: Twenty-seven patients were enrolled onto cohorts of three or six patients. PEG-IFN was administered on a weekly basis by subcutaneous injection. The dose was escalated from 180 μg/wk to a maximum of 540 μg/wk in 90-μg increments. Serial venous blood samples were drawn to assess concentrations of PEG-IFN and two immunologic surrogates, neopterin and 2′-5′ oligoadenylate synthetase (OAS). RESULTS: The maximum-tolerated dose was determined as 540 μg/wk, because two patients experienced dose-limiting toxicity within 28 days of starting treatment. One developed serum grade 3 ALT elevation, and a second developed grade 3 fatigue. Six patients were treated at 450 μg/wk without dose-limiting toxicity. Over the course of treatment, the side-effect profile was mostly mild to moderate in intensity. Adverse events included fatigue, fever, headache, myalgia, nausea, and decreased appetite. Five patients (19%) achieved a partial response. The mean maximum serum concentration increased from 5.0 to 27 ng/mL, and mean area under the curve increased from 247 to 2,981 ng/h/mL, with dose escalation from 180 μg/wk to 540 μg/wk. Serum concentration of PEG-IFN was sustained at close to peak during the dosing interval, and steady-state was achieved in approximately 5 weeks. The immunologic surrogates, neopterin and OAS, were induced at all doses with a sustained concentration profile similar to PEG-IFN. CONCLUSION: PEG-IFN is a modified form of IFNα2a with distinct pharmacokinetic advantages and immunomodulatory and antitumor activity for patients with advanced RCC. A dose of 450 μg/wk by subcutaneous administration was determined as a suitable dose for further study. PEG-IFN is more convenient to administer than IFNα and has potential for increased efficacy, less toxicity, or both. The efficacy and toxicity of PEG-IFN will be further assessed in clinical trials and compared with IFNα.

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