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      A Phase I Dose Escalation Trial of Intravenous Treosulfan in Refractory Cancer

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          Abstract

          Background: Treosulfan (Ovastat®), a bifunctional alkylating cytostatic, indicated for the treatment of advanced ovarian carcinoma, was recently found to be active in human lung and breast carcinoma xenografts. Moreover, toxicological evaluation as well as clinical experience revealed the lack of significant nonhematological toxicity which makes treosulfan a promising candidate for high-dose chemotherapy combined with autol-ogous blood stem-cell reinfusion. As a prerequisite for clinical high-dose studies, a formal phase I dose escalation without stem-cell reinfusion was conducted to reassess the maximum tolerated dose and dose-limiting toxicity of treosulfan after intravenous short-term infusion. Patients: A total of 12 patients with chemotherapy-refractory advanced cancer were entered at 3 dose levels (8 g; 10 and 12.5 g/m2 treosulfan i.v). Most patients suffered from advanced small-cell lung cancer (5 patients) or ovarian carcinoma (3 patients). Results: The maximum tolerated dose of treosulfan in this group of heavily pretreated patients was 10 g/m2. The dose-limiting toxicity was reversible thrombocytopenia. There were no nonhematological side effects exceeding WHO grade 2. Conclusions: This phase I dose escalation trial confirmed the lack of significant nonhematologic side effects of treosulfan although a dose of 12.5 g/m2 was infused. A subsequent phase I study of high-dose treosulfan followed by peripheral blood progenitor cells has therefore been initiated.

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          Author and article information

          Journal
          ONK
          Oncol Res Treat
          10.1159/issn.2296-5270
          Oncology Research and Treatment
          S. Karger AG
          2296-5270
          2296-5262
          1996
          1996
          12 May 2009
          : 19
          : 2
          : 153-156
          Affiliations
          aAbteilung Innere Medizin, Westdeutsches Krebszentrum, Essen bmedac GmbH, Hamburg
          Article
          218782 Onkologie 1996;19:153–156
          10.1159/000218782
          4e4c0dd4-e87d-4f00-ad46-ce03c384b417
          © 1996 S. Karger AG, Basel

          Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

          History
          Page count
          Pages: 4
          Categories
          Original Article

          Oncology & Radiotherapy,Pathology,Surgery,Obstetrics & Gynecology,Pharmacology & Pharmaceutical medicine,Hematology
          Ovastat®,Solid tumors,Treosulfan,Phase I trial,Dose escalation

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