Phase I Trial of O6 Benzylguanine and BCNU in Cutaneous T-cell Lymphoma
I. To determine the kinetics of AGT depletion in CTCL skin lesions. II. To determine the
toxicity of low dose BCNU plus O6BG.
OUTLINE: This is a dose-escalation study of carmustine.
Patients receive O6-benzylguanine IV over 1 hour followed by topical carmustine once every 2
weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carmustine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity.
Patients are followed for 6 weeks.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percent decrease of AGT in CTCL skin lesions, obtained from tissue samples
Point and interval estimates of response using the binomial distribution will be obtained using data from patients with measurable or evaluable disease. If responses occur, then the mean and median duration of response will be determined. Statistical significance will be determined using the t test for analysis of continuous data.
Baseline to 6 weeks
Case Western Reserve University
United States: Food and Drug Administration
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