1. Yoshi 864 (NSC 102627) 1-propanol, 3, 3'-iminodi-dimethanesulfonate (ester) hydrochloride: a phase 1 study.
- Author
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Altman SJ, Fletcher WS, Andrews NC, Wilson WL, and Pischer T
- Subjects
- Alkylating Agents administration & dosage, Alkylating Agents adverse effects, Carcinoma, Squamous Cell drug therapy, Coma chemically induced, Follow-Up Studies, Humans, Mesylates administration & dosage, Mesylates adverse effects, Narcolepsy chemically induced, Propylamines administration & dosage, Propylamines adverse effects, Propylamines therapeutic use, Remission, Spontaneous, Alkylating Agents therapeutic use, Mesylates therapeutic use, Neoplasms drug therapy
- Abstract
Yoshi 864 was given i.v. push daily times 5 with 6 weeks' followup. Dose escalation was from 0.25 mg/kg to 2.7 mg/kg. Toxicity and effectiveness were first seen at 1.5 mg/kg. Twenty-five courses were given to 16 patients at or above this level. In 16 of 22 courses, exclusive of CML, thrombopenia and/or leukopenia occurred. Mean platelet and WBC nadirs occurred on day 24 and 29 with recovery taking 1-2 weeks and 2-3 weeks respectively. Hb fell in 11 courses. At 2.7 mg/kg, nausea and vomiting lasting 6-12 days occurred in 3 of 7 courses; during 5 coures patients slept 20 hours a day, and 1 was comatose for 2 days. Two patients with squamous cell carcinoma and 1 with an unknown primary responded. Both patients with CML had clinical remissions. It is recommended that a cooperative Phase II Study in a broad spectrum of human solid tumors including lymphomas and chronic myelocytic leukemia be undertaken at a dose level of 2 mg/kg.
- Published
- 1975
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