A Phase II Study Of Hepatic Arterial Infusion Of Melphalan With Venous Filtration Via Peripheral Hepatic Perfusion (PHP) For Unresectable Primary And Metastatic Cancers Of The Liver
- 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.
- 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
PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study within 4-5 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response rate and duration of response to intra-hepatic infusion of melphalan with subsequent venous hemofiltration in patients with primary and metastatic hepatic malignancies
Marybeth Hughes, MD
NCI - Surgery Branch
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|