RATIONALE: Drugs used in chemotherapy, such as SL-11047, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of SL-11047 in treating patients with relapsed or refractory lymphoma.
OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of SL-11047 in patients with relapsed or refractory lymphoma. * Describe and quantify the toxicity of SL-11047 administered to patients with relapsed or refractory lymphoma. Secondary * Describe the pharmacokinetics of SL-11047 administered as a 30-minute IV infusion. * Assess the response rate and duration of response in patients treated with SL-11047. * Assess the level of SL-11047 within tumor tissues following intravenous administration of the drug. * Determine the sensitivity of abnormal circulating macrophages to SL-11047. OUTLINE: This is an open-label, nonrandomized, dose-escalation study. Patients receive SL-11047 IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SL-11047 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
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