Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of SJG-136 in patients with metastatic or unresectable solid tumors. II. Determine the safety and dose-limiting toxic effects of this drug in these patients. III. Determine, preliminarily, the efficacy of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the pharmacokinetic parameters of this drug and its metabolites in these patients. II. Correlate pharmacokinetic parameters with clinical effects of this drug in these patients. OUTLINE: This is an open-label, dose-escalation study. Patients receive SJG-136 intravenously (IV) over 20 minutes once daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of SJG-136 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. At least 6 patients are treated at the MTD. After completion of study treatment, patients are followed up for 30 days.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
