The study is designed to determine whether loading doxorubicin (a type of chemotherapy), when loaded onto a drug eluting microsphere will result in increased destruction of a tumor. The study will treat patients with surgically resectable liver cancers with varying doses of doxorubicin loaded into microspheres, with a close review of any side effects and chemotherapy concentrations in the bloodstream. The tumors will be surgically removed after at least 1 month, to determine how much the tumor has shrunk, and the amount of tumor destroyed. It is hoped that the study results will determine if this treatment has a role in controlling tumor growth prior to surgical removal.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
varying doses of doxorubicin loaded onto SAP during embolization procedure. Pharmacokinetic analysis of elution profile through serum concentrations over 1 month period embolization of surgically resectable HCC with superabsorbent polymer microspheres loaded with doxorubicin from a single treatment. Phase I will follow a modified Fibonacci sequence (with pharmacokinetic analysis of serum doxorubicin) to determine mean tolerated dose (MTD), severe adverse reaction (SAE) and dose limiting toxicities (DLT) when microspheres are loaded with 25mg, 50mg, or 75mg of doxorubicin. Phase II will continue enrollment with the two highest tolerated doses. At least one month after treatment, all patients will undergo imaging and surgical resection of reference tumor, with assessment of degree of necrosis, microsphere distribution, and correlation with concentration of doxorubicin loaded onto microsphere.
Vancouver General Hospital
Vancouver, British Columbia, Canada
Histopathological correlation with surgically resected tumor
Dose limiting toxicities
serum doxorubicin release patter
maximum tolerated dose
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