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Phase I and II study of high-dose ifosfamide, carboplatin, and etoposide with autologous bone marrow rescue in lymphomas and solid tumors
W.H. Wilson; V. Jain; G. Bryant; K.H. Cowan; C. Carter; M. Cottler-Fox; B. Goldspiel; S.M. Steinberg; D.L. Longo; R.E. Wittes (Profiled Author: Kenneth H Cowan)
Journal of Clinical Oncology 1992;10(11):1712-1722.Abstract
Purpose: High-dose chemotherapy produces durable disease-free remissions in a minority of patients with resistant lymphomas and solid tumors. In an attempt to improve on the available regimens, ifosfamide, carboplatin, and etoposide (ICE) were selected for a new high-dose regimen because of their favorable spectrum of nonhematopoietic toxicity and evidence of synergy in in vitro systems. Patients and Methods: Forty-one patients with drug-resistant Hodgkin's and non-Hodgkin's lymphomas, and breast and testicular cancers were entered onto a phase I and II trial of a single course of ICE with autologous bone marrow rescue. Before transplantation, all patients received combination chemotherapy until maximal tumor response was achieved. Results: Patients received total doses of ifosfamide from 10 to 18 g/m 2 , carboplatin from 0.9 to 1.98 g/m 2 , and etoposide from 0.6 to 1.5 g/m 2 administered during a 4- day period, with a maximum-tolerated dose (MTD) of ifosfamide 16 g/m 2 , carboplatin 1.8 g/m 2 , and etoposide 1.5 g/m 2 . The dose-limiting toxicities included irreversible renal, cardiac, and CNS dysfunction. There were three toxic deaths (7%), and all occurred above the MTD. Thirteen patients who were treated at the MTD tolerated the regimen well; reversible renal dysfunction and grade 2 mucositis commonly were observed. Of 23 heavily pretreated patients with persistent disease at the time of transplant, 10 (43%) achieved complete remissions (CRs) and 11 (48%) achieved partial remissions (PRs). Hodgkin's and non-Hodgkin's lymphoma patients who were treated at or below the MTD had a median potential follow-up of 11.9 months, and 12-month progression-free survivals of 62% and 48%, respectively. Conclusion: High- dose ICE with bone marrow rescue was well tolerated with a high response rate, and should be considered for further testing.
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C.E. Dunbar; A.W. Nienhuis; F.M. Stewart; P. Quesenberry; J. O'Shaughnessy; K. Cowan; M. Cottler-Fox; S. Leitman; S. Goodman; B.P. Sorrentino
Amendment to clinical research projects. Genetic marking with retroviral vectors to study the feasibility of stem cell gene transfer and the biology of hematopoietic reconstitution after autologous transplantation in multiple myeloma, chronic myelogenous leukemia, or metastatic breast cancer.Human gene therapy 1993;4(2):205-222.
Joyce A. O'Shaughnessy; Kenneth H. Cowan; Wyndham Wilson; George Bryant; Barry Goldspiel; Ronald Gress; Arthur W. Nienhuis; Cynthia Dunbar; Brian Sorrentino; F. Marc Stewart; et al.
Pilot study of high dose ICE (ifosfamide, carboplatin, etoposide) chemotherapy and autologous bone marrow transplant (ABMT) with neoR-transduced bone marrow and peripheral blood stem cells in patients with metastatic breast cancerHuman Gene Therapy 1993;4(3):331-354.
J.A. O'Shaughnessy; K.H. Cowan; A.W. Nienhuis; K.T. McDonagh; B.P. Sorrentino; C.E. Dunbar; Y. Chiang; W. Wilson; B. Goldspiel; D. Kohler; et al.Human Gene Therapy 1994;5(7):891-911.
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