A phase I study of sulofenur in refractory pediatric malignant solid tumors
Identifieur interne : 002B91 ( Main/Exploration ); précédent : 002B90; suivant : 002B92A phase I study of sulofenur in refractory pediatric malignant solid tumors
Auteurs : Charles B. Pratt [États-Unis] ; Laura C. Bowman [États-Unis] ; Neyssa Marina [États-Unis] ; Alberto Pappo [États-Unis] ; Loraine Avery [États-Unis] ; Xiaolong Luo [États-Unis] ; William H. Meyer [États-Unis]Source :
- Investigational New Drugs [ 0167-6997 ] ; 1995-03-01.
English descriptors
- KwdEn :
- Teeft :
- Additional patients, Anticancer drugs, Biochem pharmacol, Blood cells, Cancer chemother pharmacol, Clin oncol, Consecutive days, Diarylsulfonylureas, Dosage, Dosage level, Dosage levels, Ecog performance status, Further investigation, Grindey, Intermittent schedule, Malignant, Malignant triton tumor, Median, Metastatic, Methemoglobin, Methemoglobinemia, National cancer institute, Novel agent, Oncol, Pediatric, Pediatric patients, Pharmacol, Platelet, Platelet count, Progressive disease, Refractory, Rest period, Satterlee, Several groups, Solid tumors, Sulfonylurea, Sulofenur, Toxicity, Transfusion, Walling.
Abstract
Summary: The diarylsulfonylureas have shown promise in xenograft models of childhood cancer. Sulofenur has been evaluated in phase I and II trials in adults with a variety of solid tumors, but the toxicity and maximum tolerated dose of sulofenur in children and adolescents have not been determined. In a phase I study, sulofenur was administered to 13 patients with refractory pediatric malignant solid tumors. Daily dosages of 640, 800, and 960 mg/M2 in two divided oral doses were given for 5 consecutive days each week for 3 weeks. The primary and dose-limiting toxicity was methemoglobinemia, which occurred at all dose levels and required transfusions of packed red blood cells, administration of methylene blue, or both. Anemia and, less frequently, leukopenia and thrombocytopenia were also observed. A maximum tolerated daily dosage was not defined, as methemoglobinemia was noted with each dosage level. There were no measurable tumor responses. The toxicity of this agent makes it unattractive for further investigation in pediatric patients.
Url:
DOI: 10.1007/BF02614222
Affiliations:
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Bowman</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Hematology Oncology, St. Jude Children’s Research, Hospital, P.O.Box 318, 38101-0318, Memphis, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Pediatrics, University of Tennessee, Memphis College of Medicine, 38101-0318, Memphis, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author><author><name sortKey="Marina, Neyssa" sort="Marina, Neyssa" uniqKey="Marina N" first="Neyssa" last="Marina">Neyssa Marina</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Hematology Oncology, St. Jude Children’s Research, Hospital, P.O.Box 318, 38101-0318, Memphis, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Pediatrics, University of Tennessee, Memphis College of Medicine, 38101-0318, Memphis, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author><author><name sortKey="Pappo, Alberto" sort="Pappo, Alberto" uniqKey="Pappo A" first="Alberto" last="Pappo">Alberto Pappo</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Hematology Oncology, St. Jude Children’s Research, Hospital, P.O.Box 318, 38101-0318, Memphis, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Pediatrics, University of Tennessee, Memphis College of Medicine, 38101-0318, Memphis, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author><author><name sortKey="Avery, Loraine" sort="Avery, Loraine" uniqKey="Avery L" first="Loraine" last="Avery">Loraine Avery</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Hematology Oncology, St. Jude Children’s Research, Hospital, P.O.Box 318, 38101-0318, Memphis, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author><author><name sortKey="Luo, Xiaolong" sort="Luo, Xiaolong" uniqKey="Luo X" first="Xiaolong" last="Luo">Xiaolong Luo</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Tennessee</region></placeName><wicri:cityArea>Department of Biostatistics, St. Jude Children’s Research, Hospital, Memphis</wicri:cityArea></affiliation></author><author><name sortKey="Meyer, William H" sort="Meyer, William H" uniqKey="Meyer W" first="William H." last="Meyer">William H. Meyer</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Hematology Oncology, St. Jude Children’s Research, Hospital, P.O.Box 318, 38101-0318, Memphis, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Pediatrics, University of Tennessee, Memphis College of Medicine, 38101-0318, Memphis, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author></analytic><monogr></monogr><series><title level="j">Investigational New Drugs</title><title level="j" type="sub">An Interdisciplinary Journal for Clinicians and Scientists</title><title level="j" type="abbrev">Invest New Drugs</title><idno type="ISSN">0167-6997</idno><idno type="eISSN">1573-0646</idno><imprint><publisher>Kluwer Academic Publishers</publisher><pubPlace>Dordrecht</pubPlace><date type="published" when="1995-03-01">1995-03-01</date><biblScope unit="volume">13</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="63">63</biblScope><biblScope unit="page" to="66">66</biblScope></imprint><idno type="ISSN">0167-6997</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0167-6997</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>pediatric tumors</term><term>phase I studies</term><term>sulofenur</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Additional patients</term><term>Anticancer drugs</term><term>Biochem pharmacol</term><term>Blood cells</term><term>Cancer chemother pharmacol</term><term>Clin oncol</term><term>Consecutive days</term><term>Diarylsulfonylureas</term><term>Dosage</term><term>Dosage level</term><term>Dosage levels</term><term>Ecog performance status</term><term>Further investigation</term><term>Grindey</term><term>Intermittent schedule</term><term>Malignant</term><term>Malignant triton tumor</term><term>Median</term><term>Metastatic</term><term>Methemoglobin</term><term>Methemoglobinemia</term><term>National cancer institute</term><term>Novel agent</term><term>Oncol</term><term>Pediatric</term><term>Pediatric patients</term><term>Pharmacol</term><term>Platelet</term><term>Platelet count</term><term>Progressive disease</term><term>Refractory</term><term>Rest period</term><term>Satterlee</term><term>Several groups</term><term>Solid tumors</term><term>Sulfonylurea</term><term>Sulofenur</term><term>Toxicity</term><term>Transfusion</term><term>Walling</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Summary: The diarylsulfonylureas have shown promise in xenograft models of childhood cancer. Sulofenur has been evaluated in phase I and II trials in adults with a variety of solid tumors, but the toxicity and maximum tolerated dose of sulofenur in children and adolescents have not been determined. In a phase I study, sulofenur was administered to 13 patients with refractory pediatric malignant solid tumors. Daily dosages of 640, 800, and 960 mg/M2 in two divided oral doses were given for 5 consecutive days each week for 3 weeks. The primary and dose-limiting toxicity was methemoglobinemia, which occurred at all dose levels and required transfusions of packed red blood cells, administration of methylene blue, or both. Anemia and, less frequently, leukopenia and thrombocytopenia were also observed. A maximum tolerated daily dosage was not defined, as methemoglobinemia was noted with each dosage level. There were no measurable tumor responses. The toxicity of this agent makes it unattractive for further investigation in pediatric patients.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Tennessee</li></region></list><tree><country name="États-Unis"><region name="Tennessee"><name sortKey="Pratt, Charles B" sort="Pratt, Charles B" uniqKey="Pratt C" first="Charles B." last="Pratt">Charles B. Pratt</name></region><name sortKey="Avery, Loraine" sort="Avery, Loraine" uniqKey="Avery L" first="Loraine" last="Avery">Loraine Avery</name><name sortKey="Bowman, Laura C" sort="Bowman, Laura C" uniqKey="Bowman L" first="Laura C." last="Bowman">Laura C. Bowman</name><name sortKey="Bowman, Laura C" sort="Bowman, Laura C" uniqKey="Bowman L" first="Laura C." last="Bowman">Laura C. Bowman</name><name sortKey="Luo, Xiaolong" sort="Luo, Xiaolong" uniqKey="Luo X" first="Xiaolong" last="Luo">Xiaolong Luo</name><name sortKey="Marina, Neyssa" sort="Marina, Neyssa" uniqKey="Marina N" first="Neyssa" last="Marina">Neyssa Marina</name><name sortKey="Marina, Neyssa" sort="Marina, Neyssa" uniqKey="Marina N" first="Neyssa" last="Marina">Neyssa Marina</name><name sortKey="Meyer, William H" sort="Meyer, William H" uniqKey="Meyer W" first="William H." last="Meyer">William H. Meyer</name><name sortKey="Meyer, William H" sort="Meyer, William H" uniqKey="Meyer W" first="William H." last="Meyer">William H. Meyer</name><name sortKey="Pappo, Alberto" sort="Pappo, Alberto" uniqKey="Pappo A" first="Alberto" last="Pappo">Alberto Pappo</name><name sortKey="Pappo, Alberto" sort="Pappo, Alberto" uniqKey="Pappo A" first="Alberto" last="Pappo">Alberto Pappo</name><name sortKey="Pratt, Charles B" sort="Pratt, Charles B" uniqKey="Pratt C" first="Charles B." last="Pratt">Charles B. 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