Abstract |
Radioimmunotherapy targeting CD20 is a promising novel treatment for lymphoma. Prior trials have established the safe dose of Zevalin ((90)Y- ibritumomab tiuxetan; IDEC Pharmaceuticals) for patients with no more than 25% bone marrow (BM) involvement. Zevalin is expected to be an effective treatment for WM; however, the safe dose has not been defined. A phase I clinical trial has been designed to define the maximum-tolerated dose (MTD) of Zevalin in patients with WM and BM involvement up to 50%. Eligible patients need to have adequate hematologic indices (absolute neutrophil count [ANC] > 1,500/microL, platelets > 100,000/microL). The starting dose of (90)Y-Zevalin is 0.08 mCi/kg. Dose escalation by 0.04 mCi/kg in cohorts of three to six patients will be performed. Patients will be re-treated at 12 weeks if there is no complete response, no progression, and no dose-limiting toxicity. If the degree of BM involvement remains in the 20% to 50% range, re-treatment will involve a similar dose of Zevalin; if it is <20%, patients will receive Zevalin to the maximum allowed cumulative dose of 0.4 mCi/kg (or 0.3 mCi/kg for mild thrombocytopenia). Despite the phase I design, the re-treatment provision is expected to result in significant clinical benefit.
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Authors | Christos Emmanouilides |
Journal | Seminars in oncology
(Semin Oncol)
Vol. 30
Issue 2
Pg. 258-61
(Apr 2003)
ISSN: 0093-7754 [Print] United States |
PMID | 12720148
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Review)
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Copyright | Copyright 2003 Elsevier Inc. All rights reserved. |
Chemical References |
- Antibodies, Monoclonal
- Antigens, CD20
- Yttrium Radioisotopes
- ibritumomab tiuxetan
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Topics |
- Antibodies, Monoclonal
(therapeutic use)
- Antigens, CD20
- Clinical Trials, Phase I as Topic
- Humans
- Radioimmunotherapy
- Waldenstrom Macroglobulinemia
(radiotherapy)
- Yttrium Radioisotopes
(therapeutic use)
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