O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining O6-benzylguanine and carmustine in treating patients who have recurrent, metastatic, or locally advanced soft tissue sarcoma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU (Carmustine) in Patients With Advanced Soft Tissue Sarcoma|
- Disease response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||June 2000|
|Study Completion Date:||October 2002|
|Primary Completion Date:||September 2001 (Final data collection date for primary outcome measure)|
Experimental: Arm A
O6-BG as an intravenous infusion (through your vein) over 1 hour followed 1 hour later by BCNU intravenously over 15 minutes. chemotherapy every 6 weeks.
|Drug: O6-benzylguanine Drug: carmustine|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005066
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637|
|Louis A. Weiss Memorial Hospital|
|Chicago, Illinois, United States, 60640|
|Cancer Care Specialists of Central Illinois, S.C.|
|Decatur, Illinois, United States, 62526|
|Evanston Northwestern Health Care|
|Evanston, Illinois, United States, 60201|
|Division of Hematology/Oncology|
|Park Ridge, Illinois, United States, 60068|
|Oncology/Hematology Associates of Central Illinois, P.C.|
|Peoria, Illinois, United States, 61602|
|Central Illinois Hematology Oncology Center|
|Springfield, Illinois, United States, 62701|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology, Inc.|
|Fort Wayne, Indiana, United States, 46885-5099|
|Michiana Hematology/Oncology P.C.|
|South Bend, Indiana, United States, 46617|
|Study Chair:||Walter M. Stadler, MD, FACP||University of Chicago|