Phase I Study of Annamycin, a Novel Liposomal Anthracycline, in Patients with Relapsed/Refractory Acute Myeloid and Lymphoid Leukemias.
Sub-category: Leukemia/Lymphoma (Adult)
Category: Leukemia/Lymphoma (Adult)
Meeting: 2001 ASCO Annual Meeting
Abstract No: 1211
Citation: Proc Am Soc Clin Oncol 20: 2001 (abstr 1211)
Author(s): Michael Andreeff, Francis Giles, Steven Kornblau, Marina Konopleva, Clinton Leysath, C. Ellen Jackson, Kimberly Edwards, Bruce Ross, Marion Faldas, Anthony H Williams, Elihu Estey, Hagop Kantarjan, University of Texas/M.D. Anderson Cancer Center, Houston, TX; Aronex Pharmaceuticals, Inc., The Woodlands, TX.  
Abstract: Twenty-one patients with relapsed/refractory AML (n=18) or ALL (n=3) were enrolled on a dose-finding protocol using annamycin, a novel anthracycline developed to overcome multidrug resistance (MDR). Annamycin is delivered by liposomes and has not shown cardiotoxicity in preclinical studies. We have previously demonstrated that annamycin is not affected by p-glycoprotein, unlike doxorubicin and idarubicin (Blood 88:633, 1996). Annamycin, whose fundamental mechanism of action appears to be the inhibition of topoisomerase-II, was infused at a starting dose of 190 mg/m/day x 3 days with escalation to 230, 280, and 350 mg/m/day x 3 days. Annamycin was generally well tolerated with no observed cardiotoxicity. The MTD was determined at 280 mg/m/day x 3 days with grade 3/4 hepatotoxicity and mucositis observed at the higher dose level. Of the 21 patients registered, 1 was enrolled but not treated, two suffered early deaths, sixteen failed to achieve CR, and 2 achieved CR (1 AML at 280 mg/m/day who had failed induction therapy with CAT, and 1 ALL at 350 mg/m/day who relapsed after allogeneic BMT). Fifty percent of all patients cleared their circulating blasts and 43% their bone marrow blasts. MDR-1 and MRP levels were determined before, during and after treatment and were found not to prevent marrow aplasia. Conclusion: Annamycin is safe, well tolerated and shows clinical activity in patients with acute leukemias. Further evaluation of this novel anthracycline in patients with hematopoietic malignancies is warranted.
Hematological Complete Remission (HCR) and Molecular Response Induced by Liposomal All-Trans-Retinoic Acid (ATRA) in Acute Promyelocytic Leukemia (APL). Sergio S. Santillana; Marion Faldas; Anthony H. Williams; Dan Douer; Kristi A. Boehm (Profiled Author: Dan Douer) Blood 2001;96(11 PART II):217b.
Efficacy of Intravenous Liposomal All-Trans-Retinoic Acid (LipoATRA) in Children with Acute Promyelocytic Leukemia (APL). A. Wachtel, C. Pérez, J. Marcial, J. León, A. Williams, Marion Faldas, S. Santillana.  Aronex Pharmaceuticals, The Woodlands, Texas, USA; Instituto de Enfermedades Neoplasicas, Lima, Peru.  Proc Int Soc Pedtr Oncol 2001 Abstract P333  p:292.

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