Phase I study of elliptinium (2-n-methyl-9-hydroxyellipticinium) Journal Article


Authors: Einzig, A. I.; Gralla, R. J.; Leyland-Jones, B. R.; Kelsen, D. P.; Cibas, I.; Lewis, E.; Greenberg, A. E.
Article Title: Phase I study of elliptinium (2-n-methyl-9-hydroxyellipticinium)
Abstract: Elliptinium (2-N-methyl-9-hydroxyellipticinium), a chemotherapeutic agent whose mechanism of action has not been completely elucidated, intercalates into DNA. In this Phase I clinical trial, the schedule of drug administration consisted of weekly intravenous infusions. Twenty-nine patients were evaluable for toxicity. The initial dose level was 40 mg/m2 and was escalated to 150 mg/m2 through six levels. The dose-limiting side effects were emesis, xerostomia, and azotemia. The lack of myelosuppression was the most striking feature. Objective responses (partial remission, minor response) were seen in one patient each with Hodgkin's disease, non-Hodgkin's lymphoma, breast cancer, and nasopharyngeal carcinoma. We recommend a Phase II evaluation of elliptinium at a dose of 100 mg/m2 on a weekly schedule. © 1985 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted.
Keywords: adolescent; adult; cancer chemotherapy; clinical article; aged; middle aged; antineoplastic agents; neoplasms; nephrotoxicity; breast cancer; hemolysis; breast; nausea; dose-response relationship, drug; hodgkin disease; gastrointestinal toxicity; nonhodgkin lymphoma; kidney; breast carcinoma; xerostomia; nasopharynx carcinoma; drug toxicity; drug dose; phase 1 clinical trial; drug therapy; nasopharynx cancer; alkaloids; adverse drug reaction; mouth; therapy; intravenous drug administration; phlebitis; pharynx; drug evaluation; elliptinium; intoxication; uremia; drug extravasation; humans; human; male; female; drug antibody; peripheral vascular system; ellipticines
Journal Title: Cancer Investigation
Volume: 3
Issue: 3
ISSN: 0735-7907
Publisher: Informa Healthcare  
Date Published: 1985-01-01
Start Page: 235
End Page: 241
Language: English
DOI: 10.3109/07357908509039784
PUBMED: 4005651
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 26 October 2021 -- Source: Scopus
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  1. David P Kelsen
    537 Kelsen
  2. Richard J. Gralla
    69 Gralla