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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. 1990

E D Ellis, and S F Williams, and J A Moormeier, and L S Kaminer, and J D Bitran
Autologous Bone Marrow Transplantation Program, Department of Medicine, University of Chicago, Illinois.

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.

UI MeSH Term Description Entries
D008942 Mitoxantrone An anthracenedione-derived antineoplastic agent. Mitozantrone,CL-232325,DHAQ,Mitoxantrone Acetate,Mitoxantrone Hydrochloride,Mitroxone,NSC-279836,NSC-287836,NSC-299195,NSC-301739,NSC-301739D,Novantron,Novantrone,Onkotrone,Pralifan,Ralenova,Acetate, Mitoxantrone,CL 232325,CL232325,Hydrochloride, Mitoxantrone,NSC 279836,NSC 287836,NSC 299195,NSC 301739,NSC 301739D,NSC279836,NSC287836,NSC299195,NSC301739,NSC301739D
D009369 Neoplasms New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms. Benign Neoplasm,Cancer,Malignant Neoplasm,Tumor,Tumors,Benign Neoplasms,Malignancy,Malignant Neoplasms,Neoplasia,Neoplasm,Neoplasms, Benign,Cancers,Malignancies,Neoplasias,Neoplasm, Benign,Neoplasm, Malignant,Neoplasms, Malignant
D011300 Preoperative Care Care given during the period prior to undergoing surgery when psychological and physical preparations are made according to the special needs of the individual patient. This period spans the time between admission to the hospital to the time the surgery begins. (From Dictionary of Health Services Management, 2d ed) Care, Preoperative,Preoperative Procedure,Preoperative Procedures,Procedure, Preoperative,Procedures, Preoperative
D002641 Chicago A city in Illinois.
D003520 Cyclophosphamide Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer. (+,-)-2-(bis(2-Chloroethyl)amino)tetrahydro-2H-1,3,2-oxazaphosphorine 2-Oxide Monohydrate,B-518,Cyclophosphamide Anhydrous,Cyclophosphamide Monohydrate,Cyclophosphamide, (R)-Isomer,Cyclophosphamide, (S)-Isomer,Cyclophosphane,Cytophosphan,Cytophosphane,Cytoxan,Endoxan,NSC-26271,Neosar,Procytox,Sendoxan,B 518,B518,NSC 26271,NSC26271
D004341 Drug Evaluation Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals. Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D006333 Heart Failure A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION. Cardiac Failure,Heart Decompensation,Congestive Heart Failure,Heart Failure, Congestive,Heart Failure, Left-Sided,Heart Failure, Right-Sided,Left-Sided Heart Failure,Myocardial Failure,Right-Sided Heart Failure,Decompensation, Heart,Heart Failure, Left Sided,Heart Failure, Right Sided,Left Sided Heart Failure,Right Sided Heart Failure
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000206 Actuarial Analysis The application of probability and statistical methods to calculate the risk of occurrence of any event, such as onset of illness, recurrent disease, hospitalization, disability, or death. It may include calculation of the anticipated money costs of such events and of the premiums necessary to provide for payment of such costs. Analysis, Actuarial,Actuarial Analyses,Analyses, Actuarial
D013852 Thiotepa A very toxic alkylating antineoplastic agent also used as an insect sterilant. It causes skin, gastrointestinal, CNS, and bone marrow damage. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), thiotepa may reasonably be anticipated to be a carcinogen (Merck Index, 11th ed). Thio-Tepa,Thiophosphamide,Triethylenethiophosphoramide,AI3-24916,Girostan,NSC-6396,Tespa,Tespamin,Tris(1-aziridinyl)phosphine Sulfide,AI3 24916,AI324916,NSC 6396,NSC6396,Thio Tepa

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