Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Delcath Systems Inc.
With
OBJECTIVES: Primary * Determine the response rate and duration of response in patients with unresectable primary or metastatic liver cancer treated with intrahepatic arterial infusion of melphalan with venous filtration via peripheral hepatic perfusion. Secondary * Determine the patterns of recurrence in patients treated with this regimen. * Determine progression-free and overall survival of patients treated with this regimen. * Evaluate the safety and tolerability of this regimen in these patients. * Assess the filter characteristics including melphalan pharmacokinetics and filtration of cytokines and clotting factors during and after treatment. OUTLINE: Patients are stratified according to primary tumor histology (neuroendocrine tumor vs primary hepatic malignancy vs adenocarcinoma of gastrointestinal or other origin). Patients undergo peripheral isolated hepatic perfusion in which a catheter is placed via the groin into the hepatic artery and another into the hepatic vein. Patients then receive melphalan as an intrahepatic arterial infusion over 15-30 minutes. Treatment repeats approximately every 3-8 weeks for up to 6 total infusions in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 4 months for 1 year, and then periodically thereafter. PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study within 4-5 years.
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
