Preliminary efficacy and safety results of glufosfamide (GLU) in relapsed soft tissue sarcoma: Results of a phase II trial

Autor: Claire F. Verschraegen, Douglas Adkins, Stew Kroll, Kristen N. Ganjoo, Lee D. Cranmer, D. S. Mendelson, Virginia K. Langmuir, Glenn D. Rosen, G. Z. D'Amato
Rok vydání: 2008
Předmět:
Zdroj: Journal of Clinical Oncology. 26:10591-10591
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.2008.26.15_suppl.10591
Popis: 10591 Background: Glufosfamide is glucose linked to isophosphoramide mustard, the active metabolite of ifosfamide. Ifosfamide is known to have activity in soft tissue sarcoma. The objectives of this study are to evaluate the safety and efficacy of GLU in patients (pts) with soft tissue sarcoma. Methods: This 1-stage phase 2 study planned to enroll 22 pts with metastatic and/or advanced unresectable soft tissue sarcoma previously treated with 1–2 prior systemic therapies. Prior ifosfamide was allowed unless most recent relapse occurred within 4 weeks of completion of ifosfamide. Pts received GLU 5000 mg/m2 IV over 1 hour every 21 days for up to 6 cycles. Primary endpoint was confirmed response rate. FDG PET scans were collected prior to Cycle 3 if PET positive at baseline. Results: 11 male/11 female pts enrolled; 2 did not meet all eligibility criteria. Median age 52 y (range: 19–77); ECOG 0/1 (16) and 2 (6). Histology: leiomyosarcoma (8), synovial (5), angiosarcoma (3), other (6). Four pts completed 6 cyc...
Databáze: OpenAIRE