BACKGROUND: Patients with metastatic renal cell carcinoma have a poor prognosis and no standard therapy is available. The authors performed a Phase II trial of the novel agent bryostatin-1 in this patient population. METHODS: In all, 30 patients with measurable, previously untreated metastatic renal cell carcinoma were studied. Patients had excellent physiologic reserve and preserved performance status. Bryostatin-1 (25 microg/m(2)) was given in the PET (polyethyleneglycol, ethanol, and Tween 80) formulation as a 30-minute intravenous infusion on Days 1, 8, and 15 of each 28-day cycle. In general, treatment was continued until disease progression. RESULTS: Two patients had significant objective responses, although methodologic problems made interpretation difficult. The median time to progression for all patients was 2.1 months; the median overall survival was 13.1 months. The treatment was generally well tolerated. Myalgia was the most common adverse event. One patient died while on study. This was a sudden death for a patient receiving a 15th cycle of therapy. Aside from this patient (for whom the correlation of study drug to death was not clear), no Grade 4 nonhematologic toxicity was encountered in more than 150 treatment courses delivered. CONCLUSIONS: There is minimal, if any, clinically relevant single-agent activity of bryostatin-1 at this dose and schedule for patients with metastatic renal cell carcinoma. Copyright 2000 American Cancer Society.
BACKGROUND:Patients with metastatic renal cell carcinoma have a poor prognosis and no standard therapy is available. The authors performed a Phase II trial of the novel agent bryostatin-1 in this patient population. METHODS: In all, 30 patients with measurable, previously untreated metastatic renal cell carcinoma were studied. Patients had excellent physiologic reserve and preserved performance status. Bryostatin-1 (25 microg/m(2)) was given in the PET (polyethyleneglycol, ethanol, and Tween 80) formulation as a 30-minute intravenous infusion on Days 1, 8, and 15 of each 28-day cycle. In general, treatment was continued until disease progression. RESULTS: Two patients had significant objective responses, although methodologic problems made interpretation difficult. The median time to progression for all patients was 2.1 months; the median overall survival was 13.1 months. The treatment was generally well tolerated. Myalgia was the most common adverse event. One patient died while on study. This was a sudden death for a patient receiving a 15th cycle of therapy. Aside from this patient (for whom the correlation of study drug to death was not clear), no Grade 4 nonhematologic toxicity was encountered in more than 150 treatment courses delivered. CONCLUSIONS: There is minimal, if any, clinically relevant single-agent activity of bryostatin-1 at this dose and schedule for patients with metastatic renal cell carcinoma. Copyright 2000 American Cancer Society.
Authors: Amy C Peterson; Helena Harlin; Theodore Karrison; Nicholas J Vogelzang; James A Knost; John W Kugler; Eric Lester; Everett Vokes; Thomas F Gajewski; Walter M Stadler Journal: Invest New Drugs Date: 2006-03 Impact factor: 3.850
Authors: Samuel T Slocum; Andrew N Lowell; Ashootosh Tripathi; Vikram V Shende; Janet L Smith; David H Sherman Journal: Methods Enzymol Date: 2018-04-09 Impact factor: 1.600
Authors: G Deplanque; S Madhusudan; P H Jones; S Wellmann; K Christodoulos; D C Talbot; T S Ganesan; A Blann; A L Harris Journal: Br J Cancer Date: 2004-11-01 Impact factor: 7.640
Authors: S Madhusudan; A Protheroe; D Propper; C Han; P Corrie; H Earl; B Hancock; P Vasey; A Turner; F Balkwill; S Hoare; A L Harris Journal: Br J Cancer Date: 2003-10-20 Impact factor: 7.640
Authors: A R Clamp; F H Blackhall; P Vasey; M Soukop; R Coleman; G Halbert; L Robson; G C Jayson Journal: Br J Cancer Date: 2003-10-06 Impact factor: 7.640