Pilot Phase I Clinical Trial of Methioninase on High-Stage Cancer Patients: Rapid Depletion of Circulating Methionine

2019 ◽  
pp. 231-242 ◽  
Author(s):  
Robert M. Hoffman ◽  
Yuying Tan ◽  
Shukuan Li ◽  
Qinghong Han ◽  
Jorge Zavala ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Clinical Trial ◽  
Pilot Phase ◽  
High Stage

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.

A pilot, phase I clinical trial to determine the biological effects of hydroxychloroquine (HCQ) on par-4 levels in patients with surgically removable solid tumors.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. e14555-e14555
Author(s):  
Peng Wang ◽  
Heidi Weiss ◽  
Susanne M. Arnold ◽  
John L. Villano ◽  
Mark Leggas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Solid Tumors ◽  
Biological Effects ◽  
Phase I Clinical Trial ◽  
Pilot Phase

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
Sign in / Sign up

Export Citation Format

Share Document