Phase II trial of 2-chlorodeoxyadenosine in patients with relapsed/refractory acute myeloid leukemia: A study of the Eastern Cooperative Oncology Group (ECOG), E5995

2-Chlorodeoxyadenosine (2-CdA) is a purine analog which has anti-leukemic activity in phase II trials in pediatric acute myeloid leukemia (AML) patients. An adult phase I trial suggested possible similar activity although neurotoxicity at higher doses was seen. We conducted a phase II trial of 2-CdA...

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Veröffentlicht in:Leukemia research 2000-10, Vol.24 (10), p.871-875
Hauptverfasser: Gordon, Michael S, Young, Molly L, Tallman, Martin S, Cripe, Larry D, Bennett, John M, Paietta, Elisabeth, Longo, Walter, Gerad, Henry, Mazza, Joseph, Rowe, Jacob M
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container_title Leukemia research
container_volume 24
creator Gordon, Michael S
Young, Molly L
Tallman, Martin S
Cripe, Larry D
Bennett, John M
Paietta, Elisabeth
Longo, Walter
Gerad, Henry
Mazza, Joseph
Rowe, Jacob M
description 2-Chlorodeoxyadenosine (2-CdA) is a purine analog which has anti-leukemic activity in phase II trials in pediatric acute myeloid leukemia (AML) patients. An adult phase I trial suggested possible similar activity although neurotoxicity at higher doses was seen. We conducted a phase II trial of 2-CdA in patients with relapsed or refractory AML. 2-CdA was administered by continuous intravenous infusion at a dose of 17 mg/m 2 per day ×5 days. Patients not achieving aplasia by day 21 were eligible for a second course of therapy. Fifteen patients (nine relapsed and six refractory AML) were enrolled including seven men and eight women with a median age of 60 years and median ECOG PS of 1. There were five deaths on study due to infections (two), AML (two), or hepatic failure (one). The 2-CdA was well tolerated without severe nausea, vomiting or stomatitis (all
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An adult phase I trial suggested possible similar activity although neurotoxicity at higher doses was seen. We conducted a phase II trial of 2-CdA in patients with relapsed or refractory AML. 2-CdA was administered by continuous intravenous infusion at a dose of 17 mg/m 2 per day ×5 days. Patients not achieving aplasia by day 21 were eligible for a second course of therapy. Fifteen patients (nine relapsed and six refractory AML) were enrolled including seven men and eight women with a median age of 60 years and median ECOG PS of 1. There were five deaths on study due to infections (two), AML (two), or hepatic failure (one). The 2-CdA was well tolerated without severe nausea, vomiting or stomatitis (all &lt;grade 2). No severe neurologic complications related to 2-CdA were seen. Grade 4 myelosuppression occurred in nearly all patients with prolonged periods of pancytopenia and BM hypoplasia seen in most. 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An adult phase I trial suggested possible similar activity although neurotoxicity at higher doses was seen. We conducted a phase II trial of 2-CdA in patients with relapsed or refractory AML. 2-CdA was administered by continuous intravenous infusion at a dose of 17 mg/m 2 per day ×5 days. Patients not achieving aplasia by day 21 were eligible for a second course of therapy. Fifteen patients (nine relapsed and six refractory AML) were enrolled including seven men and eight women with a median age of 60 years and median ECOG PS of 1. There were five deaths on study due to infections (two), AML (two), or hepatic failure (one). The 2-CdA was well tolerated without severe nausea, vomiting or stomatitis (all &lt;grade 2). No severe neurologic complications related to 2-CdA were seen. Grade 4 myelosuppression occurred in nearly all patients with prolonged periods of pancytopenia and BM hypoplasia seen in most. There were no complete responses, though bone marrow aplasia was achieved in eight patients. 2-CdA as a single agent, in the doses used in this study, is ineffective therapy for relapsed or refractory AML.</description><subject>2-Chlorodeoxyadenosine</subject><subject>Acute myeloid leukemia</subject><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Chemotherapy</subject><subject>Cladribine - adverse effects</subject><subject>Cladribine - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Leukemia, Myeloid, Acute - drug therapy</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. 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Drug treatments</topic><topic>Purine analog</topic><topic>Recurrence</topic><topic>Salvage therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gordon, Michael S</creatorcontrib><creatorcontrib>Young, Molly L</creatorcontrib><creatorcontrib>Tallman, Martin S</creatorcontrib><creatorcontrib>Cripe, Larry D</creatorcontrib><creatorcontrib>Bennett, John M</creatorcontrib><creatorcontrib>Paietta, Elisabeth</creatorcontrib><creatorcontrib>Longo, Walter</creatorcontrib><creatorcontrib>Gerad, Henry</creatorcontrib><creatorcontrib>Mazza, Joseph</creatorcontrib><creatorcontrib>Rowe, Jacob M</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><jtitle>Leukemia research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gordon, Michael S</au><au>Young, Molly L</au><au>Tallman, Martin S</au><au>Cripe, Larry D</au><au>Bennett, John M</au><au>Paietta, Elisabeth</au><au>Longo, Walter</au><au>Gerad, Henry</au><au>Mazza, Joseph</au><au>Rowe, Jacob M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase II trial of 2-chlorodeoxyadenosine in patients with relapsed/refractory acute myeloid leukemia: A study of the Eastern Cooperative Oncology Group (ECOG), E5995</atitle><jtitle>Leukemia research</jtitle><addtitle>Leuk Res</addtitle><date>2000-10-01</date><risdate>2000</risdate><volume>24</volume><issue>10</issue><spage>871</spage><epage>875</epage><pages>871-875</pages><issn>0145-2126</issn><eissn>1873-5835</eissn><coden>LEREDD</coden><abstract>2-Chlorodeoxyadenosine (2-CdA) is a purine analog which has anti-leukemic activity in phase II trials in pediatric acute myeloid leukemia (AML) patients. An adult phase I trial suggested possible similar activity although neurotoxicity at higher doses was seen. We conducted a phase II trial of 2-CdA in patients with relapsed or refractory AML. 2-CdA was administered by continuous intravenous infusion at a dose of 17 mg/m 2 per day ×5 days. Patients not achieving aplasia by day 21 were eligible for a second course of therapy. Fifteen patients (nine relapsed and six refractory AML) were enrolled including seven men and eight women with a median age of 60 years and median ECOG PS of 1. There were five deaths on study due to infections (two), AML (two), or hepatic failure (one). The 2-CdA was well tolerated without severe nausea, vomiting or stomatitis (all &lt;grade 2). No severe neurologic complications related to 2-CdA were seen. Grade 4 myelosuppression occurred in nearly all patients with prolonged periods of pancytopenia and BM hypoplasia seen in most. There were no complete responses, though bone marrow aplasia was achieved in eight patients. 2-CdA as a single agent, in the doses used in this study, is ineffective therapy for relapsed or refractory AML.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>10996206</pmid><doi>10.1016/S0145-2126(00)00043-6</doi><tpages>5</tpages></addata></record>
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subjects 2-Chlorodeoxyadenosine
Acute myeloid leukemia
Adult
Aged
Antineoplastic agents
Antineoplastic Agents - therapeutic use
Biological and medical sciences
Chemotherapy
Cladribine - adverse effects
Cladribine - therapeutic use
Female
Humans
Leukemia, Myeloid, Acute - drug therapy
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Purine analog
Recurrence
Salvage therapy
title Phase II trial of 2-chlorodeoxyadenosine in patients with relapsed/refractory acute myeloid leukemia: A study of the Eastern Cooperative Oncology Group (ECOG), E5995
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