Phase I-II study of escalating doses of amifostine combined with high-dose cyclophosphamide.

Details

Serval ID
serval:BIB_1BC19C5583F1
Type
Article: article from journal or magazin.
Collection
Publications
Title
Phase I-II study of escalating doses of amifostine combined with high-dose cyclophosphamide.
Journal
Cancer Chemotherapy and Pharmacology
Author(s)
Ghielmini M., Van der Bosch S., Bosshard M., Pampallona S., Gabutti L., Egger H.P., Kiess M., Cavalli F., Sessa C.
ISSN
0344-5704 (Print)
ISSN-L
0344-5704
Publication state
Published
Issued date
2001
Volume
47
Number
6
Pages
532-536
Language
english
Notes
Publication types: Clinical Trial ; Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article
Publication Status: ppublish
Abstract
PURPOSE: To evaluate the feasibility and clinical effects of increasing doses of amifostine administered four times in 1 day with high-dose (HD) cyclophosphamide (CTX).
METHODS: A group of 16 patients with a diagnosis of lymphoma were treated with HD-CTX given at a total dose of 7 g/m2 subdivided into four doses, each preceded by increasing doses of amifostine. A group of 12 lymphoma patients previously treated with the same HD-CTX regimen was used as historical controls.
RESULTS: The dose of amifostine was escalated in cohorts of three patients each from 4x570 mg/m2 to 4x910 mg/m2 without severe toxic effects. Further patients were treated at the highest dose level. Side effects included a fall in blood pressure (always less than 20% of baseline value), asymptomatic hypocalcemia (from a median value of 2.4 to 1.7 mmol/l) and a decrease in creatinine clearance (from a median value of 102 to 85 ml/min). The parameters of hematotoxicity for patients treated in the study were not significantly different from those of the historical control patients.
CONCLUSIONS: Amifostine can be given safely at a dose of 910 mg/m2 four times in 1 day in combination with HD-CTX. With this schedule amifostine did not show a myeloprotective effect.
Keywords
Adolescent, Adult, Aged, Amifostine/administration & dosage, Antineoplastic Agents, Alkylating/adverse effects, Antineoplastic Agents, Alkylating/therapeutic use, Bone Marrow/drug effects, Cyclophosphamide/adverse effects, Cyclophosphamide/therapeutic use, Drug Administration Schedule, Drug Therapy, Combination, Feasibility Studies, Hodgkin Disease/drug therapy, Humans, Lymphoma, Non-Hodgkin/drug therapy, Middle Aged, Prodrugs/administration & dosage
Pubmed
Create date
24/07/2013 9:13
Last modification date
16/04/2020 5:26
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