A Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU (Carmustine) in Patients With Advanced Soft Tissue Sarcoma
OBJECTIVES: I. Determine the objective response rate of patients with recurrent, metastatic,
or locally advanced soft tissue sarcoma treated with O6-benzylguanine and carmustine. II.
Determine the toxicity of this regimen in this patient population. III. Determine the
duration of response, time to progression, and survival of these patients treated with this
regimen.
OUTLINE: Patients receive O6-benzylguanine IV over 1 hour followed 1 hour later by
carmustine IV over 15 minutes. Treatment continues every 6 weeks for a minimum of 2 courses
in the absence of unacceptable toxicity or disease progression. Patients with progressive
disease are followed every 6 months until death. Patients without progressive disease are
followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 14
months.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease response
1 year
No
Walter M. Stadler, MD, FACP
Study Chair
University of Chicago
United States: Federal Government
10227
NCT00005066
June 2000
October 2002
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Evanston Northwestern Health Care | Evanston, Illinois 60201 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
University of Illinois at Chicago | Chicago, Illinois 60612 |
Cancer Care Specialists of Central Illinois, S.C. | Decatur, Illinois 62526 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
Central Illinois Hematology Oncology Center | Springfield, Illinois 62701 |
Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne, Indiana 46885-5099 |
Michiana Hematology/Oncology P.C. | South Bend, Indiana 46617 |
Division of Hematology/Oncology | Park Ridge, Illinois 60068 |