Finding studies
Finding studies
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Lead
National Institutes of Health Clinical Center (CC)
Background: * Clinical evidence suggests that hepatic chemoembolization may prolong survival in patients with hepatic metastases. * Early studies have indicated that chemoembolization using irinotecan drug eluting beads may be more effective in treating hepatic metastases from colon or melanoma primary tumors. Objectives: * Primary Objective: --To determine the safety of hepatic chemoembolization with drug-eluting beads containing 100mg of irinotecan * Secondary Objectives: * To determine the serum pharmacokinetics and tumor tissue concentrations achieved following hepatic chemoembolization with irinotecan-eluting beads Eligibility: * Patients \> 18 years of age with pathologically proven hepatic metastases from the gastrointestinal tract, or melanoma with unresectable hepatic lesions. * Patients whose extent of hepatic metastases represents \<60% of total liver volume AND whose extrahepatic metastatic disease is determined to be minimal * Patients must be ECOG performance status of less than or equal to 2 and a life expectancy of more than 3 months. * Patients must have adequate organ function. * Patients must not have had chemotherapy, radiation therapy, or biological therapy for at least 4 weeks prior to starting study treatments. * Patients are not to receive conventional chemotherapy or therapeutic monoclonal antibodies while on study. * Patients must not have an acute, critical illness. Design: * A Phase Ib trial in which patients undergo hepatic chemoembolization with drug-eluting beads containing 100mg irinotecan. * Up to 15 patients will be enrolled over 1 year to accrue 10 evaluable patients. * Patients will undergo up to 3 chemoembolizations. * Following chemoembolization, patients will have serial serum pharmacokinetic samples drawn and tumor biopsies in order to measure serum and tumor tissue concentrations of irinotecan * Patients will be followed for one year after completion of the last treatment.
Age
18–84
Sex
ALL
Healthy volunteers
Not accepted
