Sarcoma Clinical Trial
Official title:
A Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU (Carmustine) in Patients With 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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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