Finding studies
Finding studies
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Lead
Barbara Ann Karmanos Cancer Institute
With
OBJECTIVES: * Determine the maximum tolerated dose of gemcitabine when given concurrently with bryostatin 1 to patients with advanced refractory cancer. * Access the pattern of toxicity of this drug regimen in this patient population. * Determine the objective response rate, duration of response, and overall survival in patients treated with this drug regimen. * Determine the influence of bryostatin 1 on the pharmacokinetics of gemcitabine. OUTLINE: This is a dose escalation study. Patients receive gemcitabine IV over 30 minutes, immediately followed by bryostatin 1 IV over 24 hours, weekly for 3 weeks (days 1, 8, and 15). Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of gemcitabine and bryostatin 1 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 toxic effects. PROJECTED ACCRUAL: Approximately 2-3 patients per month will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
