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Phase I Study of Amphotericin B Colloidal Dispersion for the Treatment of Invasive Fungal Infections after Marrow Transplant
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Phase I Study of Amphotericin B Colloidal Dispersion for the Treatment of Invasive Fungal Infections after Marrow Transplant
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Phase I Study of Amphotericin B Colloidal Dispersion for the Treatment of Invasive Fungal Infections after Marrow Transplant
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Journal Article
Phase I Study of Amphotericin B Colloidal Dispersion for the Treatment of Invasive Fungal Infections after Marrow Transplant
1996
Overview
Amphotericin B colloidal dispersion (ABCD; Amphocil) was evaluated in a phase I dose-escalation study in 75 marrow transplant patients with invasive fungal infections (primarily Aspergillus or Candida species) to determine the toxicity profile, maximum tolerated dose, and clinical response. Escalating doses of 0.5–8.0 mg/kg in 0.5-mg/kg/patient increments were given up to 6 weeks. No infusion-related toxicities were observed in 32% of the patients; 52% had grade 2 and 5% had grade 3 toxicity. No appreciable renal toxicity was observed at any dose level. The estimated maximum tolerated dose was 7.5 mg/kg, defined by rigors and chills and hypotension in 3 of 5 patients at 8.0 mg/kg. The complete or partial response rate across dose levels and infection types was 52%. For specific types of infections, 53% of patients with fungemia had complete responses, and 52% of patients with pneumonia had complete or partial responses. ABCD was safe at doses to 7.5 mg/kg and had tolerable infusion-related toxicity and demonstrable antifungal activity.
Publisher
The University of Chicago Press,University of Chicago Press,Oxford University Press
Subject
/ Amphotericin B - administration & dosage
/ Amphotericin B - adverse effects
/ Amphotericin B - analogs & derivatives
/ Amphotericin B - therapeutic use
/ Antibiotics. Antiinfectious agents. Antiparasitic agents
/ Antifungal Agents - administration & dosage
/ Antifungal Agents - adverse effects
/ Antifungal Agents - therapeutic use
/ Aspartate Aminotransferases - blood
/ Aspergillosis - drug therapy
/ Biological and medical sciences
/ Candida
/ Chemical and Drug Induced Liver Injury
/ Cholesterol Esters - administration & dosage
/ Cholesterol Esters - adverse effects
/ Cholesterol Esters - therapeutic use
/ Dosage
/ Fungemia
/ Grade 3
/ Humans
/ Kidney Diseases - chemically induced
