title: A phase I-II study of high-dose cyclophosphamide, thiotepa and escalating doses of mitoxantrone with autologous stem cell rescue in patients with refractory malignancies.
abstract: Twenty-five patients with refractory solid tumors were treated with high-dose cyclophosphamide, thiotepa and mitoxantrone followed by autologous stem cell rescue in a phase I dose escalation study. The dose-limiting toxic effect was mucositis at 60 mg/m2 of mitoxantrone in combination with cyclophosphamide and thiotepa. The early death rate due to toxic effects was 24%; all deaths were attributed to infections. Hematopoietic recovery was quite prolonged with median times to granulocyte (greater than 500 x 10(6)/l) and platelet (greater than 50 x 10(9)/l) recovery at 58 and 148 days, respectively. The overall response rate was 56%. The median time to progression was 14 weeks. Thus, this regimen has activity against refractory malignancies although early and prohibitive toxicity occurs when mitoxantrone is escalated in this setting.
authors.affiliation: Autologous Bone Marrow Transplantation Program, Department of Medicine, University of Chicago, Illinois.
authors.forename: E D
authors.initials: ED
authors.lastname: Ellis
authors.forename: S F
authors.initials: SF
authors.lastname: Williams
authors.forename: J A
authors.initials: JA
authors.lastname: Moormeier
authors.forename: L S
authors.initials: LS
authors.lastname: Kaminer
authors.forename: J D
authors.initials: JD
authors.lastname: Bitran
mesh_terms: D000206:Actuarial Analysis; D002641:Chicago / Q000453:epidemiology; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000627:therapeutic use*; D004341:Drug Evaluation; D006333:Heart Failure / Q000139:chemically induced; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D008942:Mitoxantrone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009369:Neoplasms / Q000601:surgery*; D011300:Preoperative Care; D015996:Survival Rate; D013852:Thiotepa / Q000008:administration & dosage / Q000627:therapeutic use*; D014182:Transplantation, Autologous / Q000401:mortality
chemical_list: D003520:Cyclophosphamide; D013852:Thiotepa; D008942:Mitoxantrone