Soluble E-selectin in cancer patients as a marker of the therapeutic efficacy of CM101, a tumor-inhibiting anti-neovascularization agent, evaluated in phase I clinical trial

1997 ◽  
Vol 123 (3) ◽  
pp. 173-179 ◽  
Author(s):  
Barbara D. Wamil ◽  
Gary B. Thurman ◽  
Hakan W. Sundell ◽  
Russell F. DeVore ◽  
Gail Wakefield ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Cancer Patients ◽  
Therapeutic Efficacy ◽  
Phase I Clinical Trial ◽  
Soluble E Selectin

Metabolism of N ?-[2-(dimethylamino)ethyl]acridine-4-carboxamide in cancer patients undergoing a phase I clinical trial

1999 ◽  
Vol 44 (1) ◽  
pp. 51-58 ◽  
Author(s):  
Philip C. Schofield ◽  
Iain G. C. Robertson ◽  
James W. Paxton ◽  
Michael R. McCrystal ◽  
Barrie D. Evans ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Clinical Trial

Measuring swainsonine in serum of cancer patients: phase I clinical trial

1994 ◽  
Vol 40 (3) ◽  
pp. 426-430 ◽  
Author(s):  
J A Baptista ◽  
P Goss ◽  
M Nghiem ◽  
J J Krepinsky ◽  
M Baker ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Cancer Patients ◽  
Biological Fluids ◽  
Competitive Inhibitor ◽  
Phase I Clinical Trial ◽  
Gas Chromatography Mass Spectrometry ◽  
Gas Liquid Chromatography ◽  
Serum Samples ◽  
Internal Standards

Abstract Swainsonine, an indolizidine alkaloid and competitive inhibitor of Golgi alpha-mannosidase II (EC 3.2.1.114), reduces tumor growth and stimulates immune function in mice. On the basis of these observations, a phase I clinical trial was initiated to determine whether swainsonine could be administered safely to cancer patients. We describe a method for extraction, acetylation, and quantification of swainsonine in human serum samples. Methyl alpha-D-mannopyranoside and methyl beta-D-galactopyranoside were added to serum samples as internal standards and, after sequential extraction of lipids and proteins with chloroform and acetonitrile, respectively, samples were acetylated with acetic anhydride and 4-dimethylaminopyridine and separated by gas-liquid chromatography. The identity of swainsonine and the internal standards after their extraction from serum and acetylation was confirmed by gas chromatography/mass spectrometry. Swainsonine was recovered at an efficiency of 90%, relative to internal standards, and calibration graphs were rectilinear from 3 to 18 mg/L with a detection limit of approximately 0.1 mg/L. The CV for multiple samples was < or = 6.7%. In patients receiving swainsonine (50-550 micrograms/kg per day) continuously for 5 days by intravenous infusion, serum concentrations of the drug reached 3-11.8 mg/L, 100 to 400 times greater than the 50% inhibitory concentration for Golgi alpha-mannosidase II and lysosomal alpha-mannosidases. Accurate measurements of swainsonine in biological fluids with this method should facilitate further clinical studies with the drug.

scholarly journals Immune response to vaccination with DNA-hsp65 in a phase I clinical trial with head and neck cancer patients

2009 ◽  
Vol 16 (7) ◽  
pp. 598-608 ◽  
Author(s):  
G D Victora ◽  
A Socorro-Silva ◽  
E C Volsi ◽  
K Abdallah ◽  
F D Lima ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Immune Response ◽  
Head And Neck Cancer ◽  
Phase I ◽  
Head And Neck ◽  
Cancer Patients ◽  
Neck Cancer ◽  
Phase I Clinical Trial

scholarly journals A New Generation of Serotype Chimeric Infectivity-Enhanced Conditionally Replicative Adenovirals: The Safety Profile of Ad5/3-Δ24 in Advance of a Phase I Clinical Trial in Ovarian Cancer Patients

2011 ◽  
Vol 22 (7) ◽  
pp. 821-828 ◽  
Author(s):  
Kenneth H. Kim ◽  
Michael J. Ryan ◽  
James E. Estep ◽  
Brock M. Miniard ◽  
Thomas L. Rudge ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Clinical Trial ◽  
Phase I ◽  
Cancer Patients ◽  
Safety Profile ◽  
Phase I Clinical Trial ◽  
New Generation
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