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Title:
Phase II trial of 6-diazo-5-oxo-L-norleucine versus aclacinomycin-A in advanced sarcomas and mesotheliomas | Investigational New Drugs
Description:
Ninety-eight patients with previously-treated advanced soft tissue sarcoma, bone sarcoma, or mesothelioma were randomly assigned to one of two intravenous single-agent treatment regimens, either 6-diazo-5-oxo-l-norleucine (DON; brief infusions of 50 mg/m2/day for 5 consecutive days every 4 weeks) or aclacinomycinA (ACM-A, as 30-min infusions of 100 mg/m2 or 85 mg/m2, administered every 3 weeks). Of 43 patients who were evaluable for response, survival and toxicity, there were two responses (5%) produced by ACM-A; one in a male with mesothelioma, and one in a female with malignant fibrous histiocytoma. None of the 36 evaluable patients treated with DON developed an objective tumor response. Median survival was 4.8 months in the DON treatment arm, and 6.8 months in the ACM-A treatment arm. No patients on the DON arm experienced lethal or life-threatening toxicities, and severe toxicities resulting from this treatment included nausea and emesis (10%), stomatitis (2%), gastrointestinal toxicity (2%), and anemia (2%). Moderate toxicities included vomiting (24%), hematologic toxicity (24%), neurologic toxicity (7%), diarrhea (7%), mucositis (5%), fever (5%), palpitations (2%), hepatotoxicity (2%), bleeding (2%) and edema (2%). Fifteen percent experienced at least one severe reaction, and 63% experienced at least one moderate or greater toxicity. ACM-A was associated with four cases of life-threatening myelosuppression (7%); severe toxicities included myelosuppression (11%), neurologic toxicity (4%), diarrhea (2%), respiratory toxicity (2%), pain and muscle spasms (2%), edema (2%), and ulceration following extravasation (2%). Moderate toxicities included diarrhea (9%), mucositis (7%), hepatotoxicity (7%), infection (5%), fever (7%), gastrointestinal toxicity (4%), respiratory (2%), dehydration (2%), cardiac (2%), alopecia (2%), ulceration following extravasation (7%), and edema (2%). Thirty-eight percent of patients on the ACM-A arm developed one or more severe or worse toxicity, and 76% had at least one moderate or worse toxicity. Neither regimen produces useful clinical results in patients with advanced sarcomas or mesotheliomas.
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google, scholar, cancer, phase, sarcomas, patients, soft, tissue, article, advanced, sarcoma, study, toxicity, rep, trial, treat, thomas, don, clin, oncol, diazooxolnorleucine, clinical, treatment, access, chemotherapy, softtissue, usa, privacy, cookies, content, mesothelioma, acma, toxicities, randomized, publish, research, search, drugs, aclacinomycina, robert, earhart, amato, chang, davis, arm, severe, included, moderate, magill, azotomycin,
Topics {βοΈ}
6-diazo-5-oxo-l-norleucine versus aclacinomycin alex yuang-chi chang 6-diazo-5-oxo-l-norleucine high-grade soft-tissue sarcomas month download article/chapter high-dose alkylation therapy high-grade softtissue sarcomas advanced soft-tissue sarcomas yuang-chi chang related subjects human neoplastic disease soft tissue sarcoma privacy choices/manage cookies soft-tissue sarcomas soft tissue sarcomas full article pdf high-dose ranimustine cyclophosphamide versus ifosfamide advanced softtissue sarcomas phase ii trial phase ii study randomized prospective trial life-threatening toxicities life-threatening myelosuppression treatment included nausea phase ii trials rochester cancer center severe toxicities resulting european economic area malignant fibrous histiocytoma von hoff dd structure-activity relationship phase ii evaluation previously untreated patients prospective randomized evaluation clinical drug development conditions privacy policy initial therapeutic observations preliminary clinical study clinical antitumor activity accepting optional cookies objective tumor response cancer research article investigational fifteen percent experienced journal finder publish 50 mg/m2/day don treatment arm harvard school advanced sarcomas
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headline:Phase II trial of 6-diazo-5-oxo-L-norleucine versus aclacinomycin-A in advanced sarcomas and mesotheliomas
description:Ninety-eight patients with previously-treated advanced soft tissue sarcoma, bone sarcoma, or mesothelioma were randomly assigned to one of two intravenous single-agent treatment regimens, either 6-diazo-5-oxo-l-norleucine (DON; brief infusions of 50 mg/m2/day for 5 consecutive days every 4 weeks) or aclacinomycinA (ACM-A, as 30-min infusions of 100 mg/m2 or 85 mg/m2, administered every 3 weeks). Of 43 patients who were evaluable for response, survival and toxicity, there were two responses (5%) produced by ACM-A; one in a male with mesothelioma, and one in a female with malignant fibrous histiocytoma. None of the 36 evaluable patients treated with DON developed an objective tumor response. Median survival was 4.8 months in the DON treatment arm, and 6.8 months in the ACM-A treatment arm. No patients on the DON arm experienced lethal or life-threatening toxicities, and severe toxicities resulting from this treatment included nausea and emesis (10%), stomatitis (2%), gastrointestinal toxicity (2%), and anemia (2%). Moderate toxicities included vomiting (24%), hematologic toxicity (24%), neurologic toxicity (7%), diarrhea (7%), mucositis (5%), fever (5%), palpitations (2%), hepatotoxicity (2%), bleeding (2%) and edema (2%). Fifteen percent experienced at least one severe reaction, and 63% experienced at least one moderate or greater toxicity. ACM-A was associated with four cases of life-threatening myelosuppression (7%); severe toxicities included myelosuppression (11%), neurologic toxicity (4%), diarrhea (2%), respiratory toxicity (2%), pain and muscle spasms (2%), edema (2%), and ulceration following extravasation (2%). Moderate toxicities included diarrhea (9%), mucositis (7%), hepatotoxicity (7%), infection (5%), fever (7%), gastrointestinal toxicity (4%), respiratory (2%), dehydration (2%), cardiac (2%), alopecia (2%), ulceration following extravasation (7%), and edema (2%). Thirty-eight percent of patients on the ACM-A arm developed one or more severe or worse toxicity, and 76% had at least one moderate or worse toxicity. Neither regimen produces useful clinical results in patients with advanced sarcomas or mesotheliomas.
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sarcoma
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headline:Phase II trial of 6-diazo-5-oxo-L-norleucine versus aclacinomycin-A in advanced sarcomas and mesotheliomas
description:Ninety-eight patients with previously-treated advanced soft tissue sarcoma, bone sarcoma, or mesothelioma were randomly assigned to one of two intravenous single-agent treatment regimens, either 6-diazo-5-oxo-l-norleucine (DON; brief infusions of 50 mg/m2/day for 5 consecutive days every 4 weeks) or aclacinomycinA (ACM-A, as 30-min infusions of 100 mg/m2 or 85 mg/m2, administered every 3 weeks). Of 43 patients who were evaluable for response, survival and toxicity, there were two responses (5%) produced by ACM-A; one in a male with mesothelioma, and one in a female with malignant fibrous histiocytoma. None of the 36 evaluable patients treated with DON developed an objective tumor response. Median survival was 4.8 months in the DON treatment arm, and 6.8 months in the ACM-A treatment arm. No patients on the DON arm experienced lethal or life-threatening toxicities, and severe toxicities resulting from this treatment included nausea and emesis (10%), stomatitis (2%), gastrointestinal toxicity (2%), and anemia (2%). Moderate toxicities included vomiting (24%), hematologic toxicity (24%), neurologic toxicity (7%), diarrhea (7%), mucositis (5%), fever (5%), palpitations (2%), hepatotoxicity (2%), bleeding (2%) and edema (2%). Fifteen percent experienced at least one severe reaction, and 63% experienced at least one moderate or greater toxicity. ACM-A was associated with four cases of life-threatening myelosuppression (7%); severe toxicities included myelosuppression (11%), neurologic toxicity (4%), diarrhea (2%), respiratory toxicity (2%), pain and muscle spasms (2%), edema (2%), and ulceration following extravasation (2%). Moderate toxicities included diarrhea (9%), mucositis (7%), hepatotoxicity (7%), infection (5%), fever (7%), gastrointestinal toxicity (4%), respiratory (2%), dehydration (2%), cardiac (2%), alopecia (2%), ulceration following extravasation (7%), and edema (2%). Thirty-eight percent of patients on the ACM-A arm developed one or more severe or worse toxicity, and 76% had at least one moderate or worse toxicity. Neither regimen produces useful clinical results in patients with advanced sarcomas or mesotheliomas.
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aclacinomycin-A
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